ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
Report
- Report Number
- 1820334-2016-01340
- Event Type
- Injury
- Date Received
- November 3, 2016
- Date of Event
- October 26, 2016
- Report Date
- May 9, 2017
- Manufacturer
- COOK INC
- Product Code
- DQY
- PMA / PMN Number
- K073378
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE, QUALITY CONTROL, SPECIFICATIONS AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED DURING THIS INVESTIGATION. THE VISUAL INSPECTION OF THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER REVEALED ONLY 5 MM OF THE BALLOON MATERIAL WAS ATTACHED TO THE CATHETER. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY ABNORMALITIES IN THE RETURNED POTION OF THE DEVICE. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THE LOT NUMBERS FOR THE RETURNED DEVICE ARE UNKNOWN; HOWEVER, THE SITE REPRESENTATIVE INDICATED THAT THE DEVICE MAY BE PART OF EITHER LOT # 6869773 OR LOT # 5952929. THE REPRESENTATIVE IS UNSURE WHICH LOT IS CORRECT. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE; SPECIFIC ITEMS ARE ADDRESSED SUCH AS: THE DEVICE DESCRIPTION FOR OVER- THE-WIRE (OTW) AND PX BALLOONS, THE END USER SHOULD: TAKE PARTICULAR CARE WHEN HANDLING THE BALLOONS TO PREVENT DAMAGE. THEY WILL INFLATE TO THE INDICATED SIZE PARAMETERS WHEN UTILIZING PROPER PRESSURE RECOMMENDATIONS. ADHERE TO THE BALLOON INFLATION PRESSURE PARAMETERS INDICATED IN THE COMPLIANCE CARD INSERT. USE OF PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. WARNINGS: DO NOT EXCEED RATED BURST PRESSURE (RBP). RUPTURE OF BALLOON MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS IN THE COMPLIANCE CARD INSERT. OVER-INFLATION MAY CAUSE RUPTURE OF BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. DO NOT USE A POWER INJECTOR FOR BALLOON INFLATION OR INJECTION OF CONTRAST MEDIUM THROUGH CATHETER LUMEN MARKED ¿DISTAL¿. RUPTURE MAY OCCUR. PRECAUTIONS: IN HEAVILY SCARRED ACCESS SITES, USE OF AN INTRODUCER SHEATH IS RECOMMENDED. THE CATHETER IS NOT INTENDED FOR THE DELIVERY OF STENTS. BASED ON ALL OF THE AVAILABLE INFORMATION, THE PATIENT'S PREEXISTING CONDITION (OCCLUDED DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY) WAS LIKELY A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE IS DEVICE FAILURE RELATED TO PATIENT CONDITION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.
(B)(4). EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE, QUALITY CONTROL, SPECIFICATIONS AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. ONE USED DEVICE WAS RETURNED TO ASSIST IN THE INVESTIGATION. ONLY 5 MM OF THE BALLOON MATERIAL WAS ATTACHED TO THE CATHETER. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY ABNORMALITIES IN THE RETURNED POTION OF THE DEVICE. THE USER FACILITY REPORTED AN ¿OCCLUDED SUPERFICIAL FEMORAL AND CALCIFIED TIBIAL-POPLITEAL ARTERY. CALCIFICATIONS CAN HAVE UNEXPECTED SHARP PROTRUSIONS WHICH CAN DAMAGE THE BALLOON AND CONTRIBUTE TO BURST AND/OR TEAR. THE CUSTOMER STATED THAT POST BALLOON RUPTURE, THE SUBJECT DEVICE SEPARATED DURING ATTEMPTED WITHDRAWAL THROUGH THE SHEATH. THE END USER STATED THAT POST BALLOON RUPTURE, THE SUBJECT DEVICE SEPARATED DURING ATTEMPTED WITHDRAWAL THROUGH THE SHEATH. POST RUPTURE, BALLOON REWRAP IS DIFFICULT WHICH CAUSED GATHERING TO OCCUR AT THE DISTAL END OF THE SHEATH, INCREASING RESISTANCE. THIS EVENTUALLY LEAD TO DEVICE SEPARATION. PER PHYSICAL DEVICE EVALUATION PERFORMED BY THE QUALITY ENGINEER: "THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. INFORMATION FROM THE END USER STATES THAT THE INITIAL RUPTURE WAS LIKELY DO TO CALCIFICATION. THE END USER STATED THAT POST BALLOON RUPTURE, THE SUBJECT DEVICE SEPARATED DURING ATTEMPTED WITHDRAWAL THROUGH THE SHEATH. POST RUPTURE, BALLOON REWRAP IS DIFFICULT WHICH CAUSED GATHERING TO OCCUR AT THE DISTAL END OF THE SHEATH, INCREASING RESISTANCE. THIS EVENTUALLY LEAD TO DEVICE SEPARATION. THE ROOT CAUSE IS DETERMINED TO BE ATTRIBUTED TO THE PATIENTS PREEXISTING CONDITION (OCCLUDED DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY). THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THE END USER STATED THAT POST BALLOON RUPTURE, THE SUBJECT DEVICE SEPARATED DURING ATTEMPTED WITHDRAWAL THROUGH THE SHEATH. POST RUPTURE, BALLOON REWRAP IS DIFFICULT WHICH CAUSED GATHERING TO OCCUR AT THE DISTAL END OF THE SHEATH, INCREASING RESISTANCE. THIS EVENTUALLY LEAD TO DEVICE SEPARATION.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
IT WAS REPORTED A BALLOON RUPTURED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND WHEN THEY TRIED TO PULL THE BALLOON BACK IT HAD BROKEN OFF INSIDE THE VESSEL AND WAS NO LONGER ON THE CATHETER. THE VESSEL WAS PRE-DILATED USING A DIFFERENT BALLOON AND RUPTURED DURING POST DILATION OF BARE METAL STENT (BMS). THE RUPTURED PIECES OF THE BALLOON WERE UNABLE TO BE RETRIEVED AND WERE SANDWICHED AGAINST THE VESSEL WALL USING A COVERED STENT. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE AS THEY HAD TO RELINE THE VESSEL WITH TWO COVERED STENTS. THE PATIENTS HEMOGLOBIN (HB) LEVEL DROPPED AND BLOOD TRANSFUSION WAS REQUIRED, REPORTEDLY NO HEMODYNAMIC COMPLICATIONS OCCURRED. AS OF THE DATE OF THIS REPORT NO OTHER INFORMATION WAS AVAILABLE.
IT WAS REPORTED A BALLOON RUPTURED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND WHEN THEY TRIED TO PULL THE BALLOON BACK IT HAD BROKEN OFF INSIDE THE VESSEL AND WAS NO LONGER ON THE CATHETER. THE VESSEL WAS PRE-DILATED USING A DIFFERENT BALLOON AND RUPTURED DURING POST DILATION OF BARE METAL STENT (BMS). THE RUPTURED PIECES OF THE BALLOON WERE UNABLE TO BE RETRIEVED AND WERE SANDWICHED AGAINST THE VESSEL WALL USING A COVERED STENT. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE AS THEY HAD TO RELINE THE VESSEL WITH TWO COVERED STENTS. THE PATIENTS HEMOGLOBIN (HB) LEVEL DROPPED AND BLOOD TRANSFUSION WAS REQUIRED, REPORTEDLY NO HEMODYNAMIC COMPLICATIONS OCCURRED. AS OF THE DATE OF THIS REPORT NO OTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726237 | ADVANCE 18 LP LOW PROFILE BALLOON CATHETER | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R |