TRUE FLOW DILATATION CATHETER
Report
- Report Number
- 2020394-2016-00935
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- September 15, 2016
- Report Date
- September 15, 2016
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- OZT
- PMA / PMN Number
- K142083
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED; THEREFORE, FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IT IS LIKELY RETRACTION ISSUES LED TO THE BALLOON JACKET DETACHMENT. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: WARNINGS: - DO NOT EXCEED THE RBP RECOMMENDED FOR THIS DEVICE. BALLOON RUPTURE MAY OCCUR IF THE RBP RATING IS EXCEEDED. TO PREVENT OVER-PRESSURIZATION, USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED. - WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION, OR CAUSE INJURY TO THE PATIENT (SUCH AS VESSEL PERFORATION). PRECAUTIONS: - IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH, DETERMINE IF CONTRAST IS TRAPPED IN THE BALLOON WITH FLUOROSCOPY. IF CONTRAST IS PRESENT, PUSH THE BALLOON OUT OF THE SHEATH AND THEN COMPLETELY EVACUATE THE CONTRAST BEFORE PROCEEDING TO WITHDRAW THE BALLOON. - IN THE VERY UNLIKELY EVENT OF BALLOON BURST OR RUPTURE, BALLOON COULD BE MORE DIFFICULT TO REMOVE THROUGH THE SHEATH AND COULD REQUIRE INTRODUCER SHEATH REMOVAL. USE OF THE TRUE¿ FLOW VALVULOPLASTY PERFUSION CATHETER: - POSITION THE BALLOON WITHIN THE RELEVANT AREA OF THE AORTIC VALVE TO BE DILATED, ENSURE THE GUIDEWIRE IS IN PLACE, AND WHILE ENSURING THE BALLOON IS HELD IN A STATIC POSITION, INFLATE THE BALLOON TO A PRESSURE NOT GREATER THAN RBP. - APPLY NEGATIVE PRESSURE TO FULLY EVACUATE FLUID FROM THE BALLOON. CONFIRM THAT THE BALLOON IS FULLY DEFLATED UNDER FLUOROSCOPY. IF BALLOON DOES NOT APPEAR TO BE FULLY DEFLATED, ENSURE PRODUCT IS OUTSIDE AORTIC VALVE IN SAFE POSITION FOR SECONDARY INFLATION. INFLATE SLIGHTLY AND DEFLATE AGAIN TO ENSURE COMPLETE DEFLATION IS ACHIEVED. - WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW DEFLATED CATHETER OVER THE GUIDEWIRE AND THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE CLOCKWISE TWISTING MOTION AY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH. - IF UNUSUAL RESISTANCE IS MET WHEN ATTEMPTING TO WITHDRAW BALLOON, POSITION BALLOON IN ANATOMICAL POSITION IN WHICH IT CAN E INFLATED SAFELY. INFLATE BALLOON AND THEN DEFLATE IT. BALLOON RE-FOLDING CAN BE OBSERVED UNDER FLUOROSCOPY. USE OF RECOMMENDED CONTRAST CONCENTRATION WILL FACILITATE FLUOROSCOPIC VISUALIZATION OF BALLOON RE-FOLDING. EQUIPMENT FOR USE: - LUER LOCK SYRINGE/INFLATION DEVICE WITH MANOMETER (50ML OR LARGER). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED; THEREFORE, FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IT IS LIKELY RETRACTION ISSUES LED TO THE BALLOON JACKET DETACHMENT. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: WARNINGS: - DO NOT EXCEED THE RBP RECOMMENDED FOR THIS DEVICE. BALLOON RUPTURE MAY OCCUR IF THE RBP RATING IS EXCEEDED. TO PREVENT OVER-PRESSURIZATION, USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED. - WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION, OR CAUSE INJURY TO THE PATIENT (SUCH AS VESSEL PERFORATION). PRECAUTIONS: - IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH, DETERMINE IF CONTRAST IS TRAPPED IN THE BALLOON WITH FLUOROSCOPY. IF CONTRAST IS PRESENT, PUSH THE BALLOON OUT OF THE SHEATH AND THEN COMPLETELY EVACUATE THE CONTRAST BEFORE PROCEEDING TO WITHDRAW THE BALLOON. - IN THE VERY UNLIKELY EVENT OF BALLOON BURST OR RUPTURE, BALLOON COULD BE MORE DIFFICULT TO REMOVE THROUGH THE SHEATH AND COULD REQUIRE INTRODUCER SHEATH REMOVAL. USE OF THE TRUE¿ FLOW VALVULOPLASTY PERFUSION CATHETER: - POSITION THE BALLOON WITHIN THE RELEVANT AREA OF THE AORTIC VALVE TO BE DILATED, ENSURE THE GUIDEWIRE IS IN PLACE, AND WHILE ENSURING THE BALLOON IS HELD IN A STATIC POSITION, INFLATE THE BALLOON TO A PRESSURE NOT GREATER THAN RBP. - APPLY NEGATIVE PRESSURE TO FULLY EVACUATE FLUID FROM THE BALLOON. CONFIRM THAT THE BALLOON IS FULLY DEFLATED UNDER FLUOROSCOPY. IF BALLOON DOES NOT APPEAR TO BE FULLY DEFLATED, ENSURE PRODUCT IS OUTSIDE AORTIC VALVE IN SAFE POSITION FOR SECONDARY INFLATION. INFLATE SLIGHTLY AND DEFLATE AGAIN TO ENSURE COMPLETE DEFLATION IS ACHIEVED. - WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW DEFLATED CATHETER OVER THE GUIDEWIRE AND THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE CLOCKWISE TWISTING MOTION AY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH. - IF UNUSUAL RESISTANCE IS MET WHEN ATTEMPTING TO WITHDRAW BALLOON, POSITION BALLOON IN ANATOMICAL POSITION IN WHICH IT CAN E INFLATED SAFELY. INFLATE BALLOON AND THEN DEFLATE IT. BALLOON RE-FOLDING CAN BE OBSERVED UNDER FLUOROSCOPY. USE OF RECOMMENDED CONTRAST CONCENTRATION WILL FACILITATE FLUOROSCOPIC VISUALIZATION OF BALLOON RE-FOLDING. EQUIPMENT FOR USE: - LUER LOCK SYRINGE/INFLATION DEVICE WITH MANOMETER (50ML OR LARGER). (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
IT WAS REPORTED THAT DURING A PULMONARY VALVULOPLASTY TO PLACE A MELODY VALVE, RESISTANCE WAS FELT WHEN ATTEMPTING TO GET THE BALLOON BACK INTO THE SHEATH FOR REMOVAL. ACCESS WAS GAINED IN THE RIGHT FEMORAL VEIN. REPORTEDLY, UNDER ECHO THE HEALTH CARE PROVIDER (HCP) NOTICED A FOREIGN BODY IN THE PULMONARY ARTERY WHICH CONFIRMED THAT THE BALLOON JACKET HAD COMPLETELY DETACHED AND WAS MOVING BACK AND FORTH FROM THE PULMONARY ARTERY AND RIGHT VENTRICLE. ANOTHER SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON JACKET BUT THE HEALTH CARE PROVIDER WAS NOT ABLE TO LOCATE THE BALLOON JACKET. REPORTEDLY, THE HCP SCHEDULED A CTA TO SEE IF A FILLING DEFECT CAN BE SEEN IN THE PULMONARY ARTERY. THE PATIENT WAS REPORTED TO BE DOING WELL.
IT WAS REPORTED THAT DURING A PULMONARY VALVULOPLASTY TO PLACE A MELODY VALVE, RESISTANCE WAS FELT WHEN ATTEMPTING TO GET THE BALLOON BACK INTO THE SHEATH FOR REMOVAL. ACCESS WAS GAINED IN THE RIGHT FEMORAL VEIN. REPORTEDLY, UNDER ECHO THE HEALTH CARE PROVIDER (HCP) NOTICED A FOREIGN BODY IN THE PULMONARY ARTERY WHICH CONFIRMED THAT THE BALLOON JACKET HAD COMPLETELY DETACHED AND WAS MOVING BACK AND FORTH FROM THE PULMONARY ARTERY AND RIGHT VENTRICLE. ANOTHER SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON JACKET BUT THE HEALTH CARE PROVIDER WAS NOT ABLE TO LOCATE THE BALLOON JACKET. REPORTEDLY, THE HCP SCHEDULED A CTA TO SEE IF A FILLING DEFECT CAN BE SEEN IN THE PULMONARY ARTERY. THE PATIENT WAS REPORTED TO BE DOING WELL.
IT WAS REPORTED THAT DURING A PULMONARY VALVULOPLASTY TO PLACE A MELODY VALVE, RESISTANCE WAS FELT WHEN ATTEMPTING TO GET THE BALLOON BACK INTO THE SHEATH FOR REMOVAL. ACCESS WAS GAINED IN THE RIGHT FEMORAL VEIN. REPORTEDLY, UNDER ECHO THE HEALTH CARE PROVIDER (HCP) NOTICED A FOREIGN BODY IN THE PULMONARY ARTERY WHICH CONFIRMED THAT THE BALLOON JACKET HAD COMPLETELY DETACHED AND WAS MOVING BACK AND FORTH FROM THE PULMONARY ARTERY AND RIGHT VENTRICLE. ANOTHER SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON JACKET BUT THE HEALTH CARE PROVIDER WAS NOT ABLE TO LOCATE THE BALLOON JACKET. REPORTEDLY, THE HCP SCHEDULED A CTA TO SEE IF A FILLING DEFECT CAN BE SEEN IN THE PULMONARY ARTERY. THE PATIENT WAS REPORTED TO BE DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663415 | TRUE FLOW DILATATION CATHETER | VALVULOPLASTY BALLOON | OZT | BARD PERIPHERAL VASCULAR, INC. | GFAU0046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |