MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-12 for SADDLELOOP 18GA ROT WITH TENSIONER 1571 manufactured by Quest Medical, Inc..
[4556480]
The hosp reported encountering an issue with the saddleloop device during a procedure. It was reported the saddle portion of the device did not hold the loop in place after anchoring to the epicardium. The hosp reported the result was total occlusion was not achieved during anastomosis. Follow up with hosp found that due to the alleged event, approx 100 minuted of ischemic time was added to the procedure. The hosp reported that the device was removed and the procedure was successfully completed using another saddleloop device (from same mfr). There were no pt complications reported as a result of this alleged event. The device was returned to the mfr for analysis.
Patient Sequence No: 1, Text Type: D, B5
[12098313]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2014-00028 |
| MDR Report Key | 3955537 |
| Report Source | 05,06 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-05-19 |
| Date Mfgr Received | 2014-05-19 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PKWY. |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SADDLELOOP 18GA ROT WITH TENSIONER |
| Generic Name | MANUAL SURGICAL INSTRUMENT |
| Product Code | GAE |
| Date Received | 2014-06-12 |
| Returned To Mfg | 2014-05-27 |
| Model Number | 1571 |
| Lot Number | 0455393C10 |
| Device Expiration Date | 2017-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ALLEN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-12 |