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

Catalog Number SGC0302

Device Problems Kinked (1339); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

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

Event Description

This is filed to report the tear noted at the distal end of the steerable guide catheter.It was reported that during a mitraclip procedure, the steerable guide catheter (sgc) was advanced into the patient anatomy; however, the sgc was unable to advance through the inferior vena cava when crossing the pelvic ridge, due to the tortuosity of the vein.Fluoroscopy was used to navigate, but resistance was felt prior to the tip reaching the right atrium.The device was removed from the anatomy, and it was noted that distal end of the sgc was kinked and torn.The sgc was replaced and the procedure was completed with implantation of one clip.Mitral regurgitation was reduced from grade 4 to grade 1-2.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: all available information was investigated and the results of the returned device analysis confirmed the reported kinked steerable guide catheter (sgc) shaft; however, the reported sgc torn shaft was not confirmed.The reported failure to advance the device into the anatomy could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).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 other incidents reported from this lot.The reported failure to advance the sgc was related to patient morphology/anatomy; specifically, due to the tortuosity of the vein.Reported kink on the shaft was a cascading effect/maneuver related to failure to advance the scg.A definitive cause for the torn material (shaft) cannot be determined, it is possible that the account has mistaken the kink as a torn, however it could not be confirmed.Based on the information reviewed, 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: 7358712
• MDR Text Key: 103282016
• Report Number: 2024168-2018-02038
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70815U140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 8FRENCH