MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 4+.Upon clip advancement it was noted that the clip moved in the opposite direction as it was being turned and would not open.Troubleshooting was performed but was unsuccessful.Subsequently, the clip was elected for exchange.The clip was retracted to the steerable guide catheter, however, the clip became stuck on the tip.The clip was unable to be retracted into the sgc, so the clip and sgc were removed simultaneously.The clip and sgc were exchanged and the procedure was completed with an mr reduction to grade 1-2.There was no clinically significant delay in the procedure and no adverse patient sequelae.The returned device analysis revealed a tear in the soft tip of the steerable guide catheter (sgc).No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported material split, cut or torn as the soft tip was observed to be torn.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and the soft tip tear appears to be related to procedural conditions associated with the clip becoming caught/stuck on the sgc soft tip.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18155697
• MDR Text Key: 328961066
• Report Number: 2135147-2023-05063
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Catalogue Number: SGC0701
• Device Lot Number: 30227R1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 99 KG