MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number M8557

Device Problems Break (1069); Needle, separation (1415)

Patient Problems Wound Dehiscence (1154); Surgical procedure, additional (2564)

Event Date 11/06/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a cabg procedure on (b)(6) 2014 and suture was used.During the procedure, the suture pulled off of the needle and the suture broke along the entire length of the closure.The patient had to be put back on-pump.Another like device was used to complete the procedure.The surgeon opines that the patient almost died due to the dehiscence.Additional information was requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

(b)(4).Unopened representative samples were returned for evaluation of suture breakage.The samples were examined for strength and the samples met the requirements.Representative samples were returned for evaluation of suture breakage.Two undispensed sutures and one partially dispensed suture were visually examined.The two undispensed sutures were intact and free of any damage or defects.The partially dispensed suture had damage consistent with damage from surgical instruments about 0.5cm from the needle juncture.The partially dispensed suture and its package showed traces of residual blood but did appear to be used in a surgical procedure.No breakages were observed for the three returned unused sutures.All needles were fastened to the sutures.No actual used suture was returned for evaluation.Unopened representative samples, two wound sutures with needles still attached and one partially wound suture with both needles still attached were returned for evaluation of suture needle pull off.Visual examination of the samples revealed no swaging anomalies.The unopened representative samples were functionally pull tested and the samples met the requirements.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch lot # hhp707, exp date: 07/2019.In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 0075 4
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4264864
• MDR Text Key: 5003814
• Report Number: 2210968-2014-16024
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M8557
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention