MAUDE Adverse Event Report: VASCUTEK GELWEAVE; GELWEAVE STRAIGHT

Model Number	731508
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - no patient information was received.(b)(4).Method: manufacturing review - review of batch manufacturing records was completed.Quality control review - review of batch qc records was completed.Results: no failure detected - from the review of manufacturing & qc records it was confirmed that the batch was manufactured to specification vascutek has requested the following information to aid the complaint investigation and we are awaiting the responses: what were the grafts being used for? were the grafts soaked in saline prior to use? if yes, for how long? was excessive tension/stretching applied to the grafts? do the patients have any coagulopathy issues or blood disorders that may have had an impact on the device's performance? how was the oozing stopped?.
Event or Problem Description
When blood transmission started, oozing was not observed, but after a while blood significantly oozed from the entire surface of the graft.Amount of blood loss is unknown.The graft was not explanted.It is unknown how the leakage was stopped.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Additional narrative: the following additional information was received about the event: it was confirmed that the graft was used for blood transmission to the axillary artery.The graft was not soaked in saline prior to use.(the ifu states that the prostheses may be briefly immersed in saline prior to implantation to improve their handling qualities) no tension or stretching was applied as the graft was cut long.The patient did not have any coagulopathy issues or blood disorders that may have had an impact on the device's performance.The oozing was not stopped, but the blood transmission to the axillary artery was completed.Vascutek's investigation found the following: the review of manufacturing records and qc test results showed that the batch was manufactured to specification.The whole graft porosity results for the batch were well below the maximum limit.A 5-year review of similar complaints (woven polyester graft leakages) gave a low occurrence rate of 0.02%.There have been no similar complaints received from other units of the batch (31 units in batch).Leakage is covered within the products risk documentation.As the graft was not available to be returned to vascutek physical analysis was not possible.Vascutek have been unable to determine the root cause of this event.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6826639
• Report Number: 9612515-2017-00013
• Device Sequence Number: 1118176
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017
• Report Date (Section F): 08/01/2017

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: 10/31/2021
• Device Model Number: 731508
• Device Catalogue Number: 731508
• Device Lot Number: 15908471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: Other