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 06/10/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the septum injury.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted and the mitraclip delivery system (cds) was advanced.During grasping attempts, the clip got caught in the chords.Troubleshooting maneuvers were used to free the clip, without causing injury.The sgc and cds had rocking motion; the sgc was no longer as stable because the sgc caused a small septum tear.The clip was not implanted and was removed, an xtw clip was implanted without issue.A total of two clips were implanted, reducing mr to 2.The atrial septal defect was treated with a 14mm closure device.No additional information was provided.

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 other incident reported from this lot.The reported adverse event of perforation is listed in the ifu as a known possible complication associated with mitraclip procedures.Based on the available information, the reported unintended movement - sgc, appears to be due to procedural circumstances.A cause for the reported perforation could not be determined.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.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12071302
• MDR Text Key: 258682683
• Report Number: 2024168-2021-05441
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10128U430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR