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

Catalog Number SGC0301

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the suspected cable break and soft tip tear.It was reported that this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr) with an mr grade of 4+.Multiple attempts were made to maneuver the steerable guide catheter (sgc), through the challenging bilateral common femoral vein with previously implanted stents.The sgc no longer responded when rotating the +/- knob and was no longer able to curve or straighten.A cable break was suspected.The device was removed and a tear was noted at the tip of the sgc.Another sgc was used.One clip was implanted, reducing mr to 2+.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: the device was returned for analysis.All available information was investigated and the reported cable break resulting mechanical issue was not confirmed via returned device analysis as the device functioned as intended.Physical resistance could not be replicated in the testing environment; however, the steerable guide catheter (sgc) soft tip was confirmed to be torn.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on this information it appears that patient anatomy likely influenced in the reported physical resistance; however, there is no indication that the patient anatomy influenced in the reported mechanical issue and cable break.A definitive cause for reported soft tip tear could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8187408
• MDR Text Key: 131168474
• Report Number: 2024168-2018-09968
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80915U148
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 74