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

Model Number SGC0701

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

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

Event Date 09/16/2021

Event Type  malfunction  

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 that would have resulted in this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, the reported difficult to remove appears to be due to user technique/procedural circumstance.The reported torn material was a cascading effect of difficult to remove.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced is filed under separate medwatch report number.

Event Description

This is filed to report difficult removal and a damaged soft tip.It was reporting this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was deployed on the mitral valve.An nt clip was inserted, but while in the anatomy, it was noted the grippers were not lowering.Troubleshooting was performed, but the issues continued to occur.Therefore, the clip was attempted to be removed.However, while removing the device, the clip became stuck on the soft tip steerable guide catheter (sgc).Both devices were able to be removed without causing a serious injury.However, it was observed that the soft tip of the sgc had become damage.A new sgc and clip delivery system (cds) were inserted.The clip was deployed on the mitral valve, reducing mr to a grade of 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 12599790
• MDR Text Key: 277199084
• Report Number: 2024168-2021-09020
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10513R312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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
• Patient Age: 79 YR