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

Catalog Number SGC0702

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

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

Event Date 02/24/2021

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 leak from the three-way stopcock of the dilator.It was reported that while preparation of the mitraclip devices, the nurse took the steerable guide catheter (sgc) and the dilator out of the package and checked them for damage, the three-way stopcock of the dilator was closed and flushed but there was a leak under the flush port of the dilator.The flush port was broken.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial filed report additional information reported that the dilator rotating hemostatic valve was broken.

Manufacturer Narrative

The returned device analysis confirmed the reported dilator rhv separation.The reported leak could not be replicated in a testing environment due to the returned condition of the device (rhv was returned separated from the 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.A review of the complaint history identified no similar complaints from the lot.Based on the information provided and the results of the device analysis the reported dilator rhv separation resulting in a leak appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.H4 medical device problem code 1069 was removed and replaced with code 1562.

• 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: 11518591
• MDR Text Key: 242676236
• Report Number: 2024168-2021-02149
• 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: 05/28/2021

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: 10/21/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 01021U216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1