MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-21 for ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) 2076-5020 manufactured by Spectranetics.
[185500773]
The patient's dob, age at time of event, gender, or weight are unknown. This information was not available from the facility. During withdrawal, the proximal portion of the scoring element detached, but remained intact to the device. Recurrence of the malfunction could result in embolism or flow limiting dissection. Patient information regarding relevant tests/ laboratory data or medical history are unknown. This information was not available from the facility. Foreign- (b)(6). The angiosculpt device was returned for evaluation. Visual inspection found a distal bond peel with one leaflet lifted, but remained intact to the device. In addition, one scoring element strut was lifted at the distal bond and detached from the intermediate bond, causing free edges. Based on the complaint details, resistance was noted during withdrawal from the sheath. It is likely that some degree of force was applied by the user, resulting in the scoring element detachment. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Patient Sequence No: 1, Text Type: N, H10
[185500794]
The angiosculpt device was used to treat the pulmonary artery and was inflated 3 times at less than 14 atm (rbp). During withdrawal through the sheath, resistance was met. Upon removal, the proximal portion of the scoring element was detached, but not totally separated. The procedure was completed with another angiosculpt device. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005462046-2020-00002 |
| MDR Report Key | 9614189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-21 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2017-05-03 |
| Date Added to Maude | 2020-01-21 |
| 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 | 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 PTA SCORING BALLOON CATHETER (OTW) |
| Generic Name | CATHETER, PERCUTANEOUS, CUTTING/SCORING |
| Product Code | PNO |
| Date Received | 2020-01-21 |
| Model Number | 2076-5020 |
| Catalog Number | 2076-5020 |
| Lot Number | G17040035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 5055 BRANDIN COURT FREMONT CA 94538 US 94538 |
| Product Code | --- |
| Date Received | 2020-01-21 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-21 |