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

Catalog Number SGC0702

Device Problems Difficult to Flush (1251); Difficult to Insert (1316)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report difficulty to flush.It was reported that during preparation of the steerable guide catheter (sgc), the device was attempted to be de-aired.However, it was noticed that no fluid could pass the dilator lumen.A wire was then inserted in an attempt to confirm access, but this wire was unable to pass the lumen.The device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed reported difficult to flush and difficult to insert dilator.A review of the lot history record revealed 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 similar incidents reported from this lot.All available information was investigated and the reported difficult to flush and difficult to insert dilator appear to be related to product quality issue.The issue is being addressed per internal operation procedure.Abbott vascular (av) will continue to trend the performance of these devices.

• 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: 11406010
• MDR Text Key: 239395938
• Report Number: 2024168-2021-01686
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 01008U134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1