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	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned and investigated.The reported difficult cds insertion through the hemostasis valve was confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported difficult to insert the cds into the sgc was due to a tear in the silicone valve within the hemostasis valve.The tear was observed at the neck of the luer causing the manufacturing slit on the silicone valve to shift.As a result there is no straight pathway for the clip to enter the slit; therefore, making it difficult for the cds to be inserted.A definitive cause for how and when the tear occurred could not be determined.It is possible that the user technique contributed to the user experience; however, this could not be confirmed.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 event is filed for a tear in the silicone valve within the hemostasis valve, which has the potential to cause or contribute to patient injury.It was reported that the patient underwent a mitraclip procedure on (b)(6) 2016, to treat degenerative mitral regurgitation (mr) of grade 4.The steerable guide catheter (sgc) and clip delivery system (cds) were prepared for use per instructions for use.The clip introducer of the cds could not pass through the hemostasis valve of the sgc and the cds was set aside.The sgc was replaced with a new sgc.The same cds was used with the new sgc and no issues were noted.The clip was deployed and the mr was reduced to grade 1.There was no adverse patient effect and no clinically significant delay.No additional information was provided.This is being reported based on returned device analysis which revealed that the silicone valve was torn.

• 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: 6034829
• Report Number: 2024168-2016-07020
• Device Sequence Number: 28255
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170630(10)60617U119
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/17/2016

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: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60617U119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/17/2016
• 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: CLIP DELIVERY SYSTEM
• Patient Age: 86 YR
• Patient Weight: 52