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

Catalog Number	SGC0101
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
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.Weight: estimated weight.(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The mitraclip instructions for use states: do not use the mitraclip system after the use by date stated on the package label, and never reuse or re-sterilize the system.Use of expired, reused, or re-sterilized devices may result in infection, endocarditis, and/or sepsis.The device was used successfully and there was no device malfunction regarding the steerable guide catheter (sgc).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report the use of an expired device.It was reported that the procedure was to treat grade 4 degenerative mitral regurgitation.One clip was successfully implanted reducing mr to grade 1.Post procedure, it was noticed that the steerable guide catheter (sgc) expired six days prior to the procedure.There was no reported adverse patient sequela.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: 6818589
• Report Number: 2024168-2017-06928
• Device Sequence Number: 13850316
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: 08717648195921
• 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): 08/24/2017

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: 08/02/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60802U114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 50