MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number	12337-04
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The perclose proglide device is filed under a separate medwatch manufacturer report reference number.Evaluation summary: analysis was performed on the returned device.The reported suture detachment could not be confirmed as the suture was not returned for analysis.A conclusive cause for the reported suture detachment could not be determined.The subsequent treatment appears to be related to procedure circumstance.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that an arteriotomy closure of the left common femoral artery was attempted using a perclose at device with a 6fr sheath, after a diagnostic procedure.Reportedly, when advancing the knot of the perclose a-t device, the suture broke.A proglide device was used and a cuff miss occurred.A non-abbott device was used to achieve hemostasis.There was no reported adverse patient sequela.The physician is reported to be in-training in the use of the perclose a-t and the proglide device.There was no reported clinically significant delay in the entire procedure.No additional information was provided.

• Brand Name: PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Common Device Name: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6156595
• Report Number: 2024168-2016-08723
• Device Sequence Number: 16241393
• Product Code: MGB
• UDI-Device Identifier: 08717648013065
• UDI-Public: (01)08717648013065(17)171118(10)60113K1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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: 11/18/2017
• Device Catalogue Number: 12337-04
• Device Lot Number: 60113K1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91