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 2013-06-26 for MALECOT M001224110 22-411 manufactured by Boston Scientific - Spencer.
[3560587]
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. A gastrostomy was performed. No additional patient complications were reported and the patient's status is stable
Patient Sequence No: 1, Text Type: D, B5
[10859518]
Device evaluated by mfr: 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 | 2134265-2013-04337 |
| MDR Report Key | 3191465 |
| Report Source | 01,05,07 |
| Date Received | 2013-06-26 |
| 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 | 2013-06-26 |
| 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 | 2013-06-26 |
| 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 | 2013-06-26 |