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

Model Number	8886612711
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); Blood Loss (2597); No Code Available (3191)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a liver transplant surgery, there was a difference in thickness of needle and the suture strand.Due the issue, the duct ruptured - resulting in tissue damage, blood loss greater than 500 cc, the surgical time extended by more than 30 minutes and there was also a extension of the incision.Another device was used to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph of the device.The visual inspection of the photographs noted two needles attached to partial sutures.There were two different types of needles and sutures observed in the photographs.As no products were returned, functional testing was precluded.The root cause of the needle diameter/appearance couldn¿t be confirmed because no products were returned.A review of the device history record indicates the product was released meeting all manufacturers¿ quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXON CV
• 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: 7203919
• Report Number: 9612501-2018-00088
• Device Sequence Number: 1174015
• Product Code: GAM
• UDI-Device Identifier: 20884523002093
• UDI-Public: 20884523002093
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 05/31/2021
• Device Model Number: 8886612711
• Device Catalogue Number: 8886612711
• Device Lot Number: D6E2415X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 04/03/2018
• 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: Life Threatening