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

Model Number N/A

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

This is filed to report the damage in the soft tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that the patient had tortuosity in the inferior vena cava.The steerable guide catheter (sgc) was inserted into the anatomy where resistance was noted.The sgc was removed, and a crack was noted on the soft tip.The sgc was replaced and one clip was implanted reducing the mr to a grade of 2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the previously filed report, additional information was received: the crack noted on the soft tip referred to a tear in the soft tip.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and based on the information provided, the difficult to insert the steerable guide catheter (sgc) resulting in soft tip tear appears to be related to patient anatomy and due to tortuosity in the inferior vena cava (ivc).There is no indication of a product issue with respect to manufacturing, design or labeling.Medical device problem code: 2889 code removed.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 15229733
• MDR Text Key: 303250359
• Report Number: 2135147-2022-00781
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0705
• Device Lot Number: 11213R123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Asian