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 2020-02-13 for IMAGER II ANGIOGRAPHIC CATHETER 38265 manufactured by Boston Scientific Corporation.
[179760310]
Device eval by manufacturer: the device was returned for analysis. The device was inspected for any damage. The device was returned in the opened sterile pouch still in the cardboard tabs. It was noticed that the device showed a broken shaft in 1 location and a separation in another location. The break was approximately 4cm from the tip and the separated portion was approximately 3cm from the tip. The separated portion was not returned. The device as manufactured is 100cm long, there was a total of 97cm returned which equals to 3cm of the tip that was not returned. There was 1 kink noticed on the shaft located approximately 20cm from the strain relief. No other damage was noticed on the devices shaft. Inspection of the remainder of the device, apart from the observed damage on the box, revealed no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[179760311]
Reportable based on device analysis completed on 24jan2020. An imager ii/5/pigtail/100/038 bx5 angiographic catheter returned with no known complaint. Device analysis found the tip was separated. It was further reported that the device was not used in a procedure. The device was tested at the hospital warehouse and was found to be fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01285 |
| MDR Report Key | 9706536 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2018-07-16 |
| Date Added to Maude | 2020-02-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 92484513-FA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGER II ANGIOGRAPHIC CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 38265 |
| Catalog Number | 38265 |
| Lot Number | 0000133448 |
| 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 | 2020-02-13 |