MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-16 for IMAGER II ANGIOGRAPHIC CATHETER 38270 manufactured by Boston Scientific Corporation.
[183568690]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183568691]
It was reported that seal compromised occurred. An imager catheter was inspected upon receipt of the device. During inspection, it was detected that imager angiographic catheter was damaged. The packaging was open on the side of the boston box. No patient was involved as it did not occur during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03306 |
| MDR Report Key | 9836323 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-09-19 |
| Date Added to Maude | 2020-03-16 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | UNIT 7 8 AND 9 |
| Manufacturer City | ANNACOTTY, LI |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGER II ANGIOGRAPHIC CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-03-16 |
| Model Number | 38270 |
| Catalog Number | 38270 |
| Lot Number | 0000145225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-16 |