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

Catalog Number SGC0702

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

Patient Problems Hypoxia (1918); Perforation (2001)

Event Date 10/14/2021

Event Type  Injury  

Event Description

This is filed to report the atrial perforation.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation with an mr grade of 3-4.The septum was floppy.Two clips were implanted without issue.However, after retracting the steerable guide catheter (sgc) into the right atrium, there was a right to left shunt with o2 oxygenation of 82%.A septal occluder was implanted and some shunt remained.During advancement of the wire to implant a second occluder, the first occluder jumped out of the septum and into the left atrium.A snare device was used to retrieve the occluder.The second occluder was placed, resolving the shunt and deficiency in oxygen.The patient left the cath lab in stable condition.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effect of cardiac perforation as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported perforation resulting in hypoxia was likely related to procedural conditions.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: 12733992
• MDR Text Key: 280522302
• Report Number: 2024168-2021-09836
• 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
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10429R244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X2)
• Patient Outcome(s): Required Intervention