MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863324-56
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during aortic valve change, on closing, the suture broke.A new device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photos noted one suture.The suture portrayed in the photo was broken.As no sealed samples were returned, functional testing could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7763065
• Report Number: 9612501-2018-01429
• Device Sequence Number: 1391993
• Product Code: GAT
• UDI-Device Identifier: 20884521062549
• UDI-Public: 20884521062549
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 88863324-56
• Device Catalogue Number: 88863324-56
• Device Lot Number: D7E2007X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 01/29/2019
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/02/2018; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR