MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-04 for PERCUFLEX M001235510 manufactured by Boston Scientific Corporation.
[129171123]
Initial reporter phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129171124]
It was reported that the string was cut and remained inside the patient's body. The treatment area was in a ureter. A percuflex ureteral catheter stent was selected for use. During procedure, after the stent has been deployed to the desired area, it was noted that the stent would also pull back while trying to remove the strings even when pressure was applied on the opposite direction. The physician decided to cut the strings at the skin; however, a portion of the string was left inside the patient's body. The procedure was completed, but the strings were left inside the patient. No further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-63311 |
| MDR Report Key | 8128398 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-04 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer City | COYOL |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUFLEX |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-12-04 |
| Model Number | M001235510 |
| Lot Number | 21892180 |
| 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 | 1. Other | 2018-12-04 |