MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer narrative.No patient information other than 'male' provided.No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.No additional harm or consequence for patient reported no apparent harm occurred in relation to the adverse event.Medical device: it was reported that pin hole leakage was observed during procedure.No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.There was no reported harm or consequence for the patient.Historical data analysis.A review of similar events related to gelweave devices was performed and gave an occurrence rate of (b)(4).There was no indication of an increasing trend and no further complaints from any of the remaining grafts from batch have been received at this time.Additional information was requested from site on procedure and if device was pre- soaked prior to procedure as per warnings and precautions in ifu.Site informed (b)(4) that device was not pre-soaked prior to procedure a review of qc and manufacturing record showed batch was manufactured to specification.All physical testing in relation to graft porosity met acceptance criteria.Investigation findings: no device problem found - no issue was found with the manufacture and testing of the complaint batch.Conclusion: as the device was not returned for investigation and from the information received, (b)(4) could not determine a root cause for this event.It is unknown if the fact that the device was not pre-soaked had any effect therefore on the performance of the device.(b)(4).Now considers this complaint closed.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.

Event Description

Event was reported to vascutek ltd as follows: dissection case, total 7 hour 30 min, acc 1 hour 50 min almost end of surgery, there was pin hole bleeding on area of graft which was not touched or clamped.Surgery has been done well.Patients has no problem.After the bleeding out, surgeon sutured point of the bleeding.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 10974335
• MDR Text Key: 242686371
• Report Number: 9612515-2020-00019
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105758
• UDI-Public: 05037881105758
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 734030-G
• Device Lot Number: 17907241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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): Required Intervention