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

Model Number SGC0701

Device Problem Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 11/02/2021

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 the reported issue. A review of the compliant history identified no similar incident reported from this lot. Based on information reviewed and without the device to analyze, a cause for the reported unintended movement in this incident could not be determined. The reported perforation appears to be a result of procedural circumstances. The reported patient effect of perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures. The reported unexpected medical intervention was a result of case specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report atrial perforation and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted a pre-existing atrial septal defect (asd). The steerable guide catheter (sgc) was advancing to the mitral valve; however, wire access was lost twice and the transseptal puncture had to be re-performed two additional times. The sgc was advanced to the mitral valve, and one clip was deployed. The physician closed the septum with a transseptal plug due to the pre-existing asd that the sgc possibly worsened. One clip was implanted, reducing mr to 2. 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: 12861778
• MDR Text Key: 281157799
• Report Number: 2024168-2021-10739
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/02/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10603R111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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: 11/23/2021 Patient Sequence Number: 1

Treatment

1 IMPLANTED MITRACLIP