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

Catalog Number SGC0702

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/13/2021

Event Type  Injury  

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 a leak.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation with a grade of 4.While inserting the clip delivery system (cds) into the steerable guide catheter (sgc), it was observed a leak occurred at the hemostatic valve of the sgc.The cds was removed and attempted to be reinserted.However, the leak continued to occur.Aspiration was then performed.The sgc was removed and replaced.Once removed, a crack was observed in the hemostatic valve.A new sgc was inserted and one clip was deployed on the mitral valve, reducing mr to a grade of <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported leak and damage reported to the hemostasis valve were confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and the leak appears to be related to the reported hemostasis valve damage and observed tear in the silicone valve of the hemostasis valve; however, a cause for the torn valve cannot be determined.The unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.D4: lot number updated.

• 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: 12737527
• MDR Text Key: 279570304
• Report Number: 2024168-2021-09844
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10519R358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention