MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-19 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851 manufactured by Boston Scientific Corporation.
[184249660]
(b)(6). Device evaluated by mfr: the device was returned for analysis. The device was received in two sections as a result of a shaft break. The device was received advanced on to the customer's guidewire. A visual and tactile examination identified a complete break of the shaft located at the shaft polymer extrusion to hypotube bond. The shaft was also noted to be severely stretched and kinked along its entire length. This type of damage is consistent with excessive tensile force being applied to the delivery system. No other issues were noted with the shaft that may have contributed to the complaint incident. A visual and tactile examination identified a complete break of the hypotube located approximately 1050mm proximal of the shaft polymer extrusion to hypotube bond. The proximal section of hypotube including the hub were not returned for analysis. The hypotube was also noted to be kinked at more than one location along its length. This type of damage is consistent with excessive tensile force being applied to the delivery system. No other issues were noted with the hypotube that may have contributed to the complaint incident. An examination of the returned device identified that the balloon had not been inflated. No issues were identified with the balloon which could potentially have contributed to this complaint. A visual and microscopic examination identified no damage to the markerbands or blades of the device. All blades were present and fully bonded to the balloon material. A microscopic examination identified no damage to the tip of the device. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[184249661]
It was reported that the catheter shaft broke. The 75% stenosed target lesion was located in the moderately tortuous and severely calcified distal left circumflex artery. A 10mmx2. 00mm wolverine coronary cutting balloon was selected for use. During the procedure, when the device was advanced, it was noted that the device was unable to cross the lesion. Furthermore, when the device was removed, it was noted that shaft separation occurred outside the patient's body. The device was simply pulled out from the patient's body and the procedure was completed with a different device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02983 |
| MDR Report Key | 9854247 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-10-11 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOLVERINE CORONARY CUTTING BALLOON MONORAIL |
| Generic Name | CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING |
| Product Code | NWX |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 3851 |
| Catalog Number | 3851 |
| Lot Number | 0022781388 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |