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 Atrial Perforation (2511)

Event Date 09/28/2020

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.The mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.During preparation of the clip delivery system (cds), one of the grippers did not lower; therefore, the cds was not used and was replaced.One clip was successfully implanted, reducing mr to a grade of 1-2.However, after removing the steerable guide catheter (sgc) a bidirectional shunt was observed.The patient¿s oxygen level did not lower; therefore, the physician decided to not place an occluder.There was no clinically significant delay in the procedure.No additional information was provided.

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.Based on the available information, the reported atrial perforation was due to procedural conditions.The reported patient effect of atrial perforation is listed in the mitraclip nt system instructions for use as a known possible complication associated with mitraclip procedures.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: 10706193
• MDR Text Key: 212141583
• Report Number: 2024168-2020-08733
• Device Sequence Number: 1
• Product Code: DRA
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 00718U104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP.; IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 69