MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON AB35SX060120135 manufactured by Spectranetics.
[183428026]
The patient's age at time of event or dob, gender, and weight are unknown. This information was not available from the facility. During inflation, the balloon ruptured. Recurrence of this malfunction could result in a prolonged intervention. No patient injury reported. Patient information regarding relevant tests/laboratory data or medical history are unknown. This information was not available from the facility. Per fda request, this mdr is being reported retrospectively. The stellarex device was discarded by the facility, thus no returned product investigation was performed. Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
Patient Sequence No: 1, Text Type: N, H10
[183428027]
During inflation, a stellarex dcb was inflated to 2 atm and immediately burst while inside the patient. The device was taken out of the patient and a new stellarex balloon was used to finish the case successfully. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009784280-2020-00068 |
| MDR Report Key | 9801408 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-10-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-10-11 |
| Date Added to Maude | 2020-03-06 |
| 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 | MRS. FLORIE CAZEM |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 510933-792 |
| Manufacturer G1 | SPECTRANETICS |
| Manufacturer Street | 6531 DUMBARTON CIRCLE |
| Manufacturer City | FREMONT CA 94555 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94555 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
| Generic Name | DCB PTA CATHETER |
| Product Code | ONU |
| Date Received | 2020-03-06 |
| Model Number | AB35SX060120135 |
| Catalog Number | AB35SX060120135 |
| Lot Number | FHV19B20A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 6531 DUMBARTON CIRCLE FREMONT CA 94555 US 94555 |
| Brand Name | PACLITAXEL, 2 ?G/MM2 |
| Product Code | --- |
| Date Received | 2020-03-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |