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

Catalog Number SGC0702

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/04/2021

Event Type  Injury  

Event Description

This is filed to report tissue damage.It was reported that this was a degenerative mitral regurgitation (mr) with a grade 4.It was noted restricted - posterior.The transseptal puncture was performed without issue; however, while advancing the steerable guide catheter (sgc), the wire flipped out of the left upper pulmonary vein and curved to the left ventricle.The sgc was retracted to the right side of the heart.After a second crossover with the transseptal catheter, a structure was observed under the transseptal puncture.Imaging of the structure was not quite clear; however, after trying to find out where this structure was coming from, it was determined that there was possible tissue damage at the septum.Additional treatment was not performed.No clips were implanted, and mr is 4.There were no adverse patient effects and 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 that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and a cause for the reported difficult positioning with the steerable guide catheter (sgc) cannot be determined.The tissue injury appears to be related to the procedural circumstances.Tissue damage is listed in the instructions for use (ifu) 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
• 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: 12871444
• MDR Text Key: 281327734
• Report Number: 2024168-2021-10803
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10303U206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other