MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	CP-424
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930)
Date of Event	02/15/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred post operatively following an intestinal laparotomy for removal of intestinal obstruction.The suture was used to close the aponeurosis via continuous stitch.Approximately 30 minutes post operatively, the patient coughed which ruptured the suture near the knot that was tied.The thread broke.The patient underwent an additional procedure to correct the ruptured suture, using a different suture.The surgical site was potentially contaminated.The patient remained hospitalized until he expired.The death of the patient resulted from the cancer itself and not from sepsis as previously reported.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device opened by the account.The visual inspection of the returned photo noted that the suture was knotted and appeared to have broken under tension.Unfortunately, because no products were returned, functional testing could not be performed.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Relevant medical history: chemotherapy and radiotherapy treatments.

• Brand Name: SURGIPRO
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7381901
• Report Number: 9612501-2018-00663
• Device Sequence Number: 16452290
• Product Code: GAW
• UDI-Device Identifier: 10884521036222
• UDI-Public: 10884521036222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 05/31/2018
• Device Model Number: CP-424
• Device Catalogue Number: CP-424
• Device Lot Number: D3E0445X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: Death
• Patient Age: 50 YR