MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) 2200-3510 manufactured by Spectranetics.
[185122848]
The patient's dob or age at time of event, and weight are unknown. This information was not available from the facility. During advancement, the angiosculpt device separated in two pieces. Although the separated portion occurred outside of the body, this is being reported conservatively. Recurrence of this malfunction could result in a prolonged procedure. Patient information regarding relevant tests/ laboratory data or medical history are unknown. This information was not available from the facility. The angiosculpt device was returned in two pieces. Visual examination found the proximal shaft separated approximately 25. 5 inches from the distal tip. No shaft buckling was noted, however 3 kinks were observed on the shaft. Based on the complaint details, manipulation of the catheter by the user caused or contributed to the shaft separation. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Patient Sequence No: 1, Text Type: N, H10
[185122849]
During insertion of the angiosculpt device into the guide catheter, resistance was felt and the proximal shaft buckled and kinked. As the physician straightened out the kink, the shaft broke in his hands. The distal portion of the device was still in the guide catheter; however, the separated portion occurred outside of the patient's body. A new device was used to complete the procedure. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005462046-2020-00003 |
| MDR Report Key | 9863084 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANA TAN |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 510933-798 |
| Manufacturer G1 | SPECTRANETICS |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) |
| Generic Name | CATHETER, PTCA, CUTTING/SCORING |
| Product Code | NWX |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 2200-3510 |
| Catalog Number | 2200-3510 |
| Lot Number | G19100006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 5055 BRANDIN COURT FREMONT CA 94538 US 94538 |
| Product Code | --- |
| Date Received | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |