MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2006-10-20 for QUANTUM MAVERICK MONORAIL 15MM X 3.25MM H7493808015320 manufactured by Boston Scientific.
[22053929]
Returned product analysis verified the difficulty stated in the complaint. Product analysis also revealed a shaft kink. The balloon catheter with the balloon in a deflated state was received and shaft kink was observed. Visual and microscopic examination of the balloon material revealed a tear in the balloon wall located 1. 7 centimeters proximally from the distal tip. The catheter also exhibited a kink in the shaft located 51. 8 centimeters distally from the edge of the strain relief. Visual and microscopic examination of the area surrounding the tear did not reveal any irregularities in the balloon material which would have contributed to the formation of the tear. The mfg records for top assembly batch 7511497 have been reviewed and no issues or discrepancies were found. This records review confirms that the device met all material, assembly, and performance specifications. The root cause of the inflation difficulties and shaft kink could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[22183773]
Determined to be reportable based on analysis completed on 9/20/06. It was reported that during a percutaneous coronary intervention procedure, inflation difficulties were encountered. The 90% stenosed and calcified lesion was located in the non-tortuous mid left anterior descending (lad) artery. The quantum maverick balloon experience reduced pressure during inflation. The number of inflations and to what atms is unk. The procedure was successfully completed with another of the same device. No pt injuries or complications were noted. Pt status is reported as "good".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000093-2006-02143 |
| MDR Report Key | 900448 |
| Report Source | 01,05,07 |
| Date Received | 2006-10-20 |
| Date of Report | 2006-08-01 |
| Date of Event | 2006-08-01 |
| Date Mfgr Received | 2006-09-20 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2007-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE - MS A210 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7632550529 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM MAVERICK MONORAIL |
| Generic Name | PTCA CATHETERS |
| Product Code | LQX |
| Date Received | 2006-10-20 |
| Returned To Mfg | 2006-08-28 |
| Model Number | 15MM X 3.25MM |
| Catalog Number | H7493808015320 |
| Lot Number | 7511497 |
| ID Number | NA |
| Device Expiration Date | 2008-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 875909 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE-SCIMED PLACE MAPLE GROVE MN 553111566 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-20 |