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

Catalog Number SGC0705

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on available information, the cause of the reported perforation cannot be determined. Perforation is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures. The reported unexpected medical intervention was the result of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional device referenced are filed under separate medwatch report number.

Event Description

This is filed to report an atrial perforation. It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. It was noted the activated clotting time (act) was greater than 250 throughout the procedure. After the clip delivery system (cds) was inserted into the left atrium (la), a thrombus like object was observed on the clip. The cds was removed and the object remained attached to the clip. Another clip was inserted and successfully deployed on the mitral valve, reducing mr to a grade of <1. However, after the steerable guide catheter (sgc), a left to right shunt was observed. Therefore, an asd closure device was implanted. There was 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: 12952370
• MDR Text Key: 281851668
• Report Number: 2024168-2021-11172
• 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

• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: SGC0705
• Device Lot Number: 10512R118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/07/2021 Patient Sequence Number: 1

Treatment

IMPLANTED MITRACLIP