MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-06-25 for MALECOT M001224110 22-411 manufactured by Boston Scientific - Spencer.
[17883733]
It was reported that during a unspecified procedure device breakage occurred. A malecot catheter had been advanced and at an unspecified time, the distal portion of the catheter broke off in the patient's stomach. Endoscopic ablation of the distal end was performed. No additional patient complications were reported and the patient's status is stable.
Patient Sequence No: 1, Text Type: D, B5
[18247923]
(b)(4). It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134265-2013-04338 |
| MDR Report Key | 3187891 |
| Report Source | 01,05,07 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-05-30 |
| Date of Event | 2013-05-28 |
| Date Mfgr Received | 2013-05-30 |
| Device Manufacturer Date | 2012-12-05 |
| Date Added to Maude | 2013-06-25 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. INGRID MATTE |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALECOT |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2013-06-25 |
| Model Number | M001224110 |
| Catalog Number | 22-411 |
| Lot Number | 0015714630 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-25 |