MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for EXPO GUIDE CATHETER 8040 manufactured by Boston Scientific Corporation.
[183178374]
It was reported that guidewire perforated the shaft. The target lesion was located in the left superior pulmonary vein. A 6f expo guide catheter and an amplatz super stiff guidewire were selected for use. The amplatz super stiff was used for the transseptal sheath to cross the left atrium. During the procedure with the expo, the transseptal dilator was removed and the expo pigtail was advanced over the wire midway up. Once the pigtail was torqued at the tip of the wire, it was seen that the wire had sheared into two parts. One part of the wire was protruding from the sidewall of the pigtail and the other had tilt through the distal tip. The wire and the catheter were removed. The procedure was completed with another of same device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02916 |
| MDR Report Key | 9825742 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-11-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | FLEXTRONICS INTERNATIONL EUROPE B V |
| Manufacturer Street | NOBLESTRAAT 10 14 |
| Manufacturer City | OOSTRUM LB 5807GA |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5807 GA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPO GUIDE CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-03-12 |
| Model Number | 8040 |
| Catalog Number | 8040 |
| Lot Number | 0060216217 |
| 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 | 2020-03-12 |