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	09/28/2016
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.The steerable guide catheter (sgc) and dilator were returned and investigated.The returned device analysis confirmed the reported loose connection between the proxy stopcocks and sgc flush port.Furthermore, cracks and stress marks were identified on the flush port.The investigation was unable to confirm the reported loose connection between the returned stopcocks and dilator flush port.A review of the lot history record revealed no manufacturing nonconformities.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 to the sgc and dilator may be attributed to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively confirmed.Furthermore, the observed crack and stress marks on the sgc flush port are likely a procedural condition of the reported loose connection when the stopcocks were unable to securely tighten.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 that during preparation, the stopcock connection to the steerable guiding catheter (sgc) hemostasis valve and to the dilator would not stay secure, which if used, has the potential to cause or contribute to patient injury.It was reported that during preparation of the steerable guiding catheter (sgc 60721u135), the stopcock was connected to the sgc hemostasis valve, but would unspin.Five stopcocks were attempted, but the same thing occurred with all of the devices.The sgc was not used in the anatomy, and was replaced.The new sgc was used with one of the previously attempted stopcocks successfully.Next, one of the previous stopcocks were connected to the dilator flush port from the first sgc pack (60721u135), but the stopcock would unspin.The dilator was not used and was replaced with the dilator from the new sgc.The new dilator was used successfully with the previously attempted stopcock.There was no patient involvement and 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: 6049450
• Report Number: 2024168-2016-07219
• Device Sequence Number: 888829
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170721(10)60721U135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112239
• 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): 10/21/2016

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: 07/21/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60721U135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1