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

Model Number SGC0701

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Split, Cut or Torn (4008)

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

Event Date 04/30/2021

Event Type  malfunction  

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 incidents reported from this lot. Based on the information reviewed, the reported difficult to insert and failure to advance the steerable guide catheter (sgc) appear to be due to challenging patient anatomy. The reported torn soft tip appears to be a result of the reported difficult to insert and failure to advance. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a tear in the steerable guide catheter (sgc) soft tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) 4+. During insertion of the steerable guide catheter (sgc), there was difficulty and due to the tortuosity at the groin level, the sgc was not able to advance past the iliac artery. When the sgc was retracted, the soft tip was noted to be torn. Therefore, a new sgc was used successfully in the procedure. Two clips implanted, reducing mr to 1-2. There was no adverse patient effect 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: 11878346
• MDR Text Key: 252705296
• Report Number: 2024168-2021-04383
• Device Sequence Number: 1
• Product Code: DRA
• 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: distributor,health profession

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/21/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10122U256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial