MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0702

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

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.The additional sgc referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the kink in the sgc tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During advancement of the steerable guide catheter (sgc), resistance was met and the distal tip bent therefore the sgc was removed.The same issue occurred with the second sgc so the decision was made to use the left femoral access.One clip was implanted, reducing mr to <1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Return device analysis did not confirm the reported deformed sgc soft tip.However, a kink in the sgc shaft was observed.The reported failure to advance could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated, and the reported failure to advance appears to be due to challenging patient anatomy.The observed kinked sgc shaft appears to be a cascading event of the failure to advance.There is no indication of product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12485591
• MDR Text Key: 271899427
• Report Number: 2024168-2021-08234
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10310U206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1