MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problems Break (1069); Positioning Failure (1158); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.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 the suspected cable break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The inferior vena cava was heavily tortuous.The steerable guiding catheter (sgc), failed to cross the septum due to the tortuous vena cava.While in the right atrium, the -/+ knob was no longer curving or straightening.A cable break was suspected.The sgc was removed and a new sgc was used.There was no adverse patient effect and no clinically significant delay during the procedure.Two clips were implanted, reducing mr to 2.The patient was reported as doing well.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported failure to advance could not be tested as this was related to patient anatomy and procedural conditions.The reported positioning failure (unable to curve and unable to straighten) could not be confirmed during the returned device analysis as the device functioned as intended (was able to curve and straighten without any issue).The reported break (cable break) could not be confirmed during the returned device analysis as all the cables were noted to be intact (not broken).Additionally, the analysis observed a kink in the braided distal shaft.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have influenced the reported issues.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.Based on the available information, the reported failure to advance was due to challenging patient anatomy (heavily tortuous inferior vena cava).The observed deformation due to compressive stress (braided shaft) was a cascading effect of the reported failure to advance the sgc through the septum.A definite cause for the reported positioning failure (unable to curve and unable to straighten) and the reported break (cable break) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10155290
• MDR Text Key: 195365892
• Report Number: 2024168-2020-05038
• 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
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00205U158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1