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

Catalog Number SGC0702

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is being filed to report the steerable guide catheter leak during preparation.It was reported that during preparation of the steerable guide catheter (sgc) it failed to hold column, the rubber lip did not hold tight, so air got into the system.The three-way stopcock closed and connected correctly.There was no visible damage to the rubber lip.The sgc was tested three times but was unsuccessful; therefore, the sgc was not used in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.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 leak and inadequate valve seal in this complaint could not be determined.The returned device analysis was unable to confirm the reported issues.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11581965
• MDR Text Key: 243921830
• Report Number: 2024168-2021-02468
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 00912U149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1