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

Catalog Number SGC0302

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report torn material.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc 80925u240) was inserted into the groin with the dilator; however, the sgc could not advance over the wire into the femoral vein.The sgc was retracted when the dilator was pushed back into the sgc soft tip.The shaft became kinked, and the soft tip had an incision-like damage, and appeared to be torn.It was later noted that during preparation of the sgc, force was applied to advance the dilator out of the sgc.The sgc was removed and replaced.A new sgc was used to complete the procedure.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: all available information was investigated, and kink on steerable guide catheter (sgc) shaft confirmed via returned device analysis.Furthermore, material deformation on sgc soft tip was observed.However, difficulty advancing dilator or tear was not confirmed.A review of the lot history record revealed no manufacturing nonconformities in this lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All the available information was investigated and, reported kink and observed material deformation on sgc soft tip appear to be due to user technique/procedural circumstances.A definitive cause for the reported difficult to advance dilator could not be determined.There is no indication of 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: 8664220
• MDR Text Key: 147166832
• Report Number: 2024168-2019-04330
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80925U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1