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

Catalog Number SGC0702

Device Problems Product Quality Problem (1506); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 02/22/2022

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.

Event Description

This is filed to report the soft tip damage.It was reported this was a mitraclip procedure performed to treat grade 4 functional mitral regurgitation (mr).The steerable guide catheter (sgc) would not advance smoothly into the vein.It was noted the radiopaque ring and distal shaft and soft tip began to fold, compressing like an accordion.The sgc was removed and a replacement sgc was used without issue.An xtw clip was successfully implanted, mr was reduced to 1.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the radiopaque ring, distal shaft and soft tip folding and the kink on the steerable guide catheter (sgc) shaft.However, the reported failure to advance could not be replicated in a testing environment as it is related to patient anatomy/procedural operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots and a review of the complaint history identified no similar incident reported from this lot.Based on available information, a cause for the reported failure to advance could not be determined.Additionally, the reported kink and irregular appearance were cascading events of reported failure to advance.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13862533
• MDR Text Key: 289468844
• Report Number: 2024168-2022-03003
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 11005R152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1