CATERPILLAR EMBOLIZATION SYSTEM
Report
- Report Number
- 9616666-2021-00006
- Event Type
- Malfunction
- Date Received
- February 2, 2021
- Date of Event
- January 4, 2021
- Report Date
- July 21, 2021
- Manufacturer
- CLEARSTREAM TECHNOLOGIES LTD.
- Product Code
- KRD
- UDI-DI
- 00801741155307
- PMA / PMN Number
- K191532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. HOWEVER, DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE, PREMATURE DETACHMENT, POOR IMAGE QUALITY AND DEVICE INCOMPATIBILITY ISSUES. THE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND PREMATURE DETACHMENT POOR IMAGE QUALITY AND DEVICE INCOMPATIBILITY ISSUES COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. LABELING REVIEW: THE INSTRUCTION FOR USE FOR THE CATERPILLAR ARTERIAL EMBOLIZATION SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: PRECAUTIONS: VERIFY THAT THE DELIVERY CATHETER THAT IS USED IS COMPATIBLE WITH THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES PRIOR TO USE (SECTION J). IF EXCESSIVE RESISTANCE BEYOND WHAT WOULD BE EXPECTED IS ENCOUNTERED AT ANY POINT DURING ADVANCEMENT OF THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES THROUGH THE DELIVERY CATHETER, STOP AND REMOVE THE DEVICE AND DELIVERY CATHETER AS ONE UNIT/TOGETHER. DO NOT TWIST OR ROTATE THE DELIVERY WIRE DURING ADVANCEMENT, BECAUSE THE IMPLANT MAY DETACH PREMATURELY. WARNINGS: THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES SHOULD BE ADVANCED AND/OR MANIPULATED UNDER FLUOROSCOPIC GUIDANCE. IF THE DEVICE CAN NOT BE ADEQUATELY VISUALIZED UNDER FLUOROSCOPY, REMOVE AND DISCARD THE DEVICE AND USE AN ALTERNATIVE DEVICE. PRECAUTIONS: CHECK THAT THE DEVICE HAS NOT BEEN DAMAGED PRIOR TO USE. DO NOT USE IF ANY DAMAGE IS VISIBLE OR IF ANY PART OF THE IMPLANT IS OUTSIDE OF THE LOADER. IF LOADER OR WIRE KINKS OR BECOMES DAMAGED DURING PREPARATION, DO NOT USE THE DEVICE. THE DEVICE SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN ENDOVASCULAR PROCEDURES AND ARE FAMILIAR WITH THE COMPLICATIONS, SIDE EFFECTS AND HAZARDS OF PERIPHERAL VASCULAR INTERVENTIONS. THE PHYSICIAN SHOULD DETERMINE APPROPRIATE PATIENT COMPATIBILITY WITH THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES PRIOR TO USE. IN PARTICULAR, THE PHYSICIAN SHOULD DETERMINE THAT THE PRODUCT DIMENSIONS ARE APPROPRIATE FOR THE IMPLANT AREA. IF EXCESSIVE RESISTANCE BEYOND WHAT WOULD BE EXPECTED IS ENCOUNTERED AT ANY POINT DURING ADVANCEMENT OF THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES THROUGH THE DELIVERY CATHETER, STOP AND REMOVE THE DEVICE AND DELIVERY CATHETER AS ONE UNIT/TOGETHER. POTENTIAL ADVERSE EVENTS: IMPLANT MALPOSITION/MISALIGNMENT. CAUTION: DO NOT ADVANCE OR RETRACT THE CATERPILLAR¿ AND CATERPILLAR¿ MICRO ARTERIAL EMBOLIZATION DEVICES FROM THE LOADER WITHOUT ATTACHING THE LOADER VIA THE TUOHY BORST TO THE DELIVERY CATHETER HUB. H10: B5, B7, D4 (EXPIRY DATE: 12/2021), G3, H6 (DEVICE, METHOD). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 BD. H3: DEVICE NOT RETURNED.
H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. HOWEVER, DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE, PREMATURE DETACHMENT, POOR IMAGE QUALITY AND DEVICE INCOMPATIBILITY ISSUES. THE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE, PREMATURE DETACHMENT, POOR IMAGE QUALITY AND DEVICE INCOMPATIBILITY ISSUES COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. LABELING REVIEW: THE INSTRUCTION FOR USE FOR THE CATERPILLAR ARTERIAL EMBOLIZATION SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: PRECAUTIONS: ¿ VERIFY THAT THE DELIVERY CATHETER THAT IS USED IS COMPATIBLE WITH THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES PRIOR TO USE (SECTION J). ¿ IF EXCESSIVE RESISTANCE BEYOND WHAT WOULD BE EXPECTED IS ENCOUNTERED AT ANY POINT DURING ADVANCEMENT OF THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES THROUGH THE DELIVERY CATHETER, STOP AND REMOVE THE DEVICE AND DELIVERY CATHETER AS ONE UNIT/TOGETHER. ¿ DO NOT TWIST OR ROTATE THE DELIVERY WIRE DURING ADVANCEMENT, BECAUSE THE IMPLANT MAY DETACH PREMATURELY. WARNINGS ¿ THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES SHOULD BE ADVANCED AND/OR MANIPULATED UNDER FLUOROSCOPIC GUIDANCE. IF THE DEVICE CAN NOT BE ADEQUATELY VISUALIZED UNDER FLUOROSCOPY, REMOVE AND DISCARD THE DEVICE AND USE AN ALTERNATIVE DEVICE. PRECAUTIONS ¿ CHECK THAT THE DEVICE HAS NOT BEEN DAMAGED PRIOR TO USE. DO NOT USE IF ANY DAMAGE IS VISIBLE OR IF ANY PART OF THE IMPLANT IS OUTSIDE OF THE LOADER. IF LOADER OR WIRE KINKS OR BECOMES DAMAGED DURING PREPARATION, DO NOT USE THE DEVICE. ¿ THE DEVICE SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN ENDOVASCULAR PROCEDURES AND ARE FAMILIAR WITH THE COMPLICATIONS, SIDE EFFECTS AND HAZARDS OF PERIPHERAL VASCULAR INTERVENTIONS. THE PHYSICIAN SHOULD DETERMINE APPROPRIATE PATIENT COMPATIBILITY WITH THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES PRIOR TO USE. IN PARTICULAR, THE PHYSICIAN SHOULD DETERMINE THAT THE PRODUCT DIMENSIONS ARE APPROPRIATE FOR THE IMPLANT AREA. ¿ IF EXCESSIVE RESISTANCE BEYOND WHAT WOULD BE EXPECTED IS ENCOUNTERED AT ANY POINT DURING ADVANCEMENT OF THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES THROUGH THE DELIVERY CATHETER, STOP AND REMOVE THE DEVICE AND DELIVERY CATHETER AS ONE UNIT/TOGETHER. POTENTIAL ADVERSE EVENTS ¿ IMPLANT MALPOSITION/MISALIGNMENT CAUTION: DO NOT ADVANCE OR RETRACT THE CATERPILLAR AND CATERPILLAR MICRO ARTERIAL EMBOLIZATION DEVICES FROM THE LOADER WITHOUT ATTACHING THE LOADER VIA THE TUOHY BORST TO THE DELIVERY CATHETER HUB. H10: D4 (EXPIRY DATE: 12/2021), G3 H11: D4 (MEDICAL DEVICE LOT NUMBER) H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : DEVICE NOT RETURNED.
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS DIFFICULT TO ADVANCE AND WAS NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE APPEARED DETACHED PREMATURELY, UNABLE TO BE VISUALIZED UNDER FLUOROSCOPY AND DEVICE INCOMPATIBILITY. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS DIFFICULT TO ADVANCE AND WAS NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE APPEARED DETACHED PREMATURELY, UNABLE TO BE VISUALIZED UNDER FLUOROSCOPY AND DEVICE DEVICE INCOMPATIBILITY. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 12/2021).
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS DIFFICULT TO ADVANCE AND WAS NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE APPEARED DETACHED PREMATURELY. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164361 | CATERPILLAR EMBOLIZATION SYSTEM | ARTERIAL EMBOLIZATION DEVICE | KRD | CLEARSTREAM TECHNOLOGIES LTD. | CTP027015U | CMEN0027 | 00801741155307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |