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

Model Number SGC0701

Device Problems Leak/Splash (1354); Material Separation (1562); Unstable (1667)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report unstable rhv cap.It was reported that during preparation of the steerable guide catheter (sgc), the tuohy [rhv cap] would not tighten enough.It is thought that there was aggressive tightening and loosening during this step.Ultimately, the tuohy was really tried to be closed and it snapped off from the sgc.The device was not used and there was no patient involvement.A new sgc was used to continue the procedure.There was no clinically significant delay in the procedure.Reportedly all steps were performed per the instructions for use (ifu).No additional information was provided.

Event Description

This is filed to report unstable rhv cap and leak.It was reported that during preparation of the steerable guide catheter (sgc), the tuohy [rhv cap] would not tighten enough.It is thought that there was aggressive tightening and loosening during this step.Ultimately, the tuohy was really tried to be closed and it snapped off from the sgc.The device was not used and there was no patient involvement.A new sgc was used to continue the procedure.There was no clinically significant delay in the procedure.Reportedly all steps were performed per the instructions for use (ifu).Subsequent to the initially filed report, the following information was provided: the rhv cap would not tighten enough to close off air.Every time it was flushed, the flush always came out no matter how tight the cap was.There was no more resistance than usual when tightening and loosening the rhv cap.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 identified no similar complaints reported from this lot.The investigation determined the reported rhv detachment appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.The reported leak was a cascading event of reported difficult to close rhv cap.Abbott 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: 12339235
• MDR Text Key: 267250111
• Report Number: 2024168-2021-07284
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1