MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CL-928
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hernia (2240); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient was operated with multiple left pulmonary (oncological) resections by mini thoracotomy, during the weekend, the patient had a progressive subcutaneous emphysema and a thoracotomy dehiscence with pulmonary herniation, that was confirmed by ct scan, the patient had to undergo mini thoracotomy because of ruptured sutures.This was verified on the 6th postoperative day during patient reoperation.Upon reaching the plane of the thoracotomy, the rupture (tear) of the three sutures in "x" was verified for the costal approach, with integrity of the surgical knots.The sutures were separated from each other several centimeters and were not exposed to any cutting or erosive structure, so that only a material failure is plausible.The patient is still hospitalized.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of fifteen representative samples of device sealed.Visual inspection of the returned photographs revealed the suture which was knotted and in several pieces.Visual inspection and functional testing of the returned devices confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of fifteen devices.Visual inspection of the returned photographs revealed it was knotted and in several pieces.The returned opened product consisted of one partial suture that was also the subject of the returned images.The suture was knotted and broken.Visual inspection and functional testing of the returned sealed devices confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7768507
• Report Number: 9612501-2018-01442
• Device Sequence Number: 2218483
• Product Code: GAM
• UDI-Device Identifier: 10884521043459
• UDI-Public: 10884521043459
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CL-928
• Device Catalogue Number: CL-928
• Device Lot Number: D8C0677X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 01/08/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/21/2018; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention