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	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: analysis was performed on the returned device.The reported needle to cuff miss was confirmed as a needle to cuff detachment/ suture retrieval issue.Analysis of the returned device found a cuff tab detachment.Cuff tabs measure one one-hundredth (0.01) of an inch square and due to the extremely small size; a missing cuff tab is not visible without magnification and would not be noted by the user.The reported difficulty appears to be related to interaction with the patient calcification.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.Additionally, a review of the complaint history identified no similar 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 arteriotomy closure of a calcified right common femoral artery was attempted using a perclose at device via a 5f sheath after a diagnostic procedure.Reportedly, the device did not deploy due to calcification; a cuff miss was noted.A proglide device was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure.The physician is reportedly trained in the use of the perclose at and proglide devices.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: 6851917
• Report Number: 2024168-2017-07353
• Device Sequence Number: 19232534
• Product Code: MGB
• UDI-Device Identifier: 08717648013065
• UDI-Public: 08717648013065
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/08/2017

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: 01/07/2018
• Device Catalogue Number: 12337-04
• Device Lot Number: 60119K1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/08/2017
• 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: 5F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR