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

Model Number	VP-331X
Medical Device Problem Codes	Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
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 during an open aortic valve replacement procedure.The suture was being used while closing the hole from the cannula of the lv venting.The suture was treated or hydrated prior to use with saline.When the user performed the first throw hold at two hours into the procedure, the surface of the suture frayed.As a result, could not proceed with the suture.In order to resolve the issue and complete the case, used another suture from the same packaging.Also, a needle of another suture from the same packaging was detached from the strand while the nurse tried to pull the suture with the needle holder out of the package.There was no patient harm.The patient outcome is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted one suture and one needle.The suture was received heavily frayed along the whole length.As no sealed samples were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all 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: SURGIPRO II
• 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: 6976301
• Report Number: 9612501-2017-06490
• Device Sequence Number: 1495757
• Product Code: GAW
• UDI-Device Identifier: 20884521037639
• UDI-Public: 20884521037639
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 07/31/2021
• Device Model Number: VP-331X
• Device Catalogue Number: VP-331X
• Device Lot Number: D6G0501X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1