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

Catalog Number SGC0705

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

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 additional device referenced in b5 is being filed under a separate medwatch report number.

Event Description

This is filed to report soft tip damage.It was reported that during advancement into the anatomy through the leg, both steerable guide catheters (sgc) could not advance due to the anatomy and the tips became damaged and wrinkled.The anatomy was very tortuous.The procedure was aborted.There were no adverse patient effects and there was no reported 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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined the reported failure to advance appears to be related to patient morphology/pathology.The damaged and wrinkled soft tip was a cascading effect of the failure to advance; therefore, attributed to procedural condition.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: 11995254
• MDR Text Key: 256216339
• Report Number: 2024168-2021-04951
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10212U111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 75