MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-09-28 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE EH7716LG manufactured by Ethicon, Inc..
[2883471]
It was reported that a patient underwent a mitral valve replacement procedure on (b)(6) 2012 and suture was used. The needle pulled off the suture when knotting the suture at the valve ring. The surgeon used an endoscopic camera and made an incision in the great vessel to locate the needle. The needle was removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
[10137030]
Date sent to the fda: (b)(4) 2012. (b)(4). Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information: the actual device batch number associated with this event is not known. The international affiliate reports the following possible batch numbers: (b)(4). In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[10270702]
(b)(4). Conclusion: the actual sample returned for evaluation is composed by 1 needle still swaged to a part of thread and a detached needle. The visual inspection of the swaging area does not reveal any defect. Conclusion: representative samples from the same lot number as the actual device were returned for evaluation. The devices were tested for needle pull tensile strength test and the devices met performance specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-05660 |
| MDR Report Key | 2764783 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-09-04 |
| Date of Event | 2012-09-04 |
| Date Facility Aware | 2012-09-04 |
| Date Mfgr Received | 2012-10-16 |
| Date Added to Maude | 2012-09-28 |
| 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 | 3 |
| Manufacturer Contact | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON. SAS AUNEAU |
| Manufacturer Street | NEUILLY SUR SEINE, FRANCE |
| Manufacturer City | AUNEAU NI |
| Manufacturer Country | FR |
| Manufacturer Postal Code | NI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2012-09-28 |
| Returned To Mfg | 2012-10-05 |
| Model Number | NA |
| Catalog Number | EH7716LG |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-28 |