MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number	SGC0101
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device and a non-abbott stopcock were returned and investigated.The reported loose/intermittent connection was unable to be confirmed as the stopcock was able to be securely attached to the steerable guide catheter (sgc).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 reported from this lot.All available information was investigated and the reported loose/intermittent connection is possibly related to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively determined.The returned device analysis confirmed that the sgc flush port functioned as expected.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
This is filed to report the stopcock connection which, if the device was used, has the potential to cause or contribute to patient injury.It was reported that during preparation of the steerable guiding catheter (sgc), the stopcock was attached to the flush port of the sgc, but would come undone.Three different stopcocks were attempted, but all would not stay connected.The sgc was not used in the anatomy and was replaced.A new sgc was used without issue.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Common Device Name: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6082914
• Report Number: 2024168-2016-07657
• Device Sequence Number: 287890
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170331(10)60308U147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161985
• 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): 11/07/2016

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: 03/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60308U147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/07/2016
• 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: NAVILYST MEDICAL NAMIC STOPCOCK