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 2020-03-23 for INTERLOCK-35 83786 manufactured by Boston Scientific Corporation.
[184472147]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184472148]
It was reported that the coil made a hole in the catheter. Vascular access was obtained via ipsilateral approach in a moderately calcified internal iliac artery. During the procedure, two to three coils were placed even though the angle was steep. A 15mmx40cm interlock-35 was selected and the coil became not smooth upon advancing when it reached the curve part of the proximal side of the interlocking arm. Coil movement inside the catheter became suspicious. When the remaining coil (about 2cm) was tried to insert, the locking arm got separated. The coil was pulled back by recoiling and it penetrated the 5fr non-bsc angiographic catheter and created a hole. After that, it was tried to push using a non-bsc device, but the locking arm section came in contact with the hole of the damaged catheter. Thus, the coil became unable to advance further and was then removed together with the catheter. The coil was able to be removed outside the body. The procedure was completed with another of the same device. No complications reported and the patient is stable with no adverse health hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03656 |
| MDR Report Key | 9865556 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-23 |
| 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 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLOCK-35 |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-23 |
| Model Number | 83786 |
| Catalog Number | 83786 |
| Lot Number | 0024024993 |
| 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 | 2020-03-23 |