MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER

Model Number SGC0701

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.All available information was investigated, and the reported kinked braided shaft was confirmed via returned device analysis.The reported difficult to advance and difficult to remove could not be replicated under the testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar complaints reported for this lot.The cause for the reported difficult to advance and difficult to remove were likely due to patient anatomy (narrow vessel).The reported kinked braided shaft was a result of the difficult to advance.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report difficult removal.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr), with an mr grade of 4.When inserting the steerable guide catheter (sgc), into the groin resistance was felt with the narrow vessel.The sgc was able to advance and one clip was implanted without issues.Mr was reduced to 3.Upon removal of the sgc, it was noted that the sgc shaft was kinked.There was no clinically significant delay in the procedure and no adverse patient effects.The following information was provided on the medwatch report: after deployment of the clip it seemed to get caught at a point that wasn't normal.The device felt a bit difficult on guide insertion and it was thought maybe there was some narrowing in the femoral vein.Upon removal, it resisted a bit at the groin and a fluoro was shot and the physician noticed that the device was kinked or a small bend at the tip of the guide.There was no harm to the patient and the procedure successful and no other device was used.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: STEERABLE GUIDING CATHETER
• 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: 10963062
• MDR Text Key: 220977329
• Report Number: 2024168-2020-10243
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00709U146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• 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: 65 YR
• Patient Weight: 81