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

Model Number CP-424

Device Problems Break (1069); Unraveled Material (1664)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 02/15/2018

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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 Description

Relevant medical history: chemotherapy and radiotherapy treatments.

• Brand Name: SURGIPRO
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7381901
• MDR Text Key: 103836480
• Report Number: 9612501-2018-00663
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10884521036222
• UDI-Public: 10884521036222
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• 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): Death
• Patient Age: 50 YR