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

Catalog Number SGC0705

Device Problems Break (1069); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guiding catheter (sgc) shaft break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The steerable guiding catheter (sgc), could not be inserted into the inguinal region and the distal shaft broke, kinked and bent after several attempts.The inguinal region was dilated with a balloon and a new sgc was used without further issue.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 complaints reported from this lot.The investigation determined the reported difficulty inserting the device appears to be related to morphology/pathology.The reported broken and kinked shaft were results of the difficulty inserting.There is no indication of a 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: 11128414
• MDR Text Key: 225565914
• Report Number: 2024168-2021-00179
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01013U114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 62