MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-05

Device Problems Unsealed Device Packaging (1444); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an arteriotomy closure of a common femoral artery was attempted using a proglide device with a 6f sheath after an interventional coronary procedure.Reportedly, the proglide suture broke during suture harvesting.Another proglide device was used to achieve hemostasis.There was no reported adverse patient sequela.There was no clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

Device codes: 1444 labeled.Internal file number - (b)(4).Correction: device code 1104 removed.Evaluation summary: visual inspections were performed on the returned device.The reported unsealed device packaging could not be confirmed as the packaging was not returned.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported packaging issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Subsequent to filing of the initial medwatch report additional information was received.It was reported that when the sterilized package of the proglide device was opened the inner packaging was a little open at the corner.Because the package was a little open in the corner it was not used.There was no patient contact.Returned device analysis identified blood in and on the device, therefore, this will remain reportable as a serious injury event as the correct device was confirmed to have been returned.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8479096
• MDR Text Key: 140791304
• Report Number: 2024168-2019-02588
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 12673-05
• Device Lot Number: 8011042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FHEPARIN; SHEATH: 6FHEPARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 62