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

Model Number SGC0701

Device Problems Crack (1135); Difficult to Flush (1251); Loose or Intermittent Connection (1371); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

All information was investigated and the reported loose or intermittent connection, difficulty/inability to flush and device contamination with chemical or other material was confirmed via returned device analysis. The investigation determined that the reported loose flush port connection, difficulty/inability to flush and obstruction inside the flush port is the result of the observed flush port contamination with plastic piece. The reported crack on the luer was likely due to the clear plastic inside the luer making it appear to be a crack. The broken plastic piece was sent to the materials characterization lab for chemical analysis. Results indicate the material is comparable to the sample 3 way plastic stopcock. 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 other complaints from the lot. The investigation identified the contamination of the luer with a plastic piece as a potential product issue. The issue is being addressed per internal operating procedures. Abbott will continue to trend the performance of these devices.

Event Description

This is filed to report the difficulty flushing the device. It was reported that during preparation of the steerable guide catheter, the side port looked cracked and the physician could not hook the 3-way stopcock and there was difficulty flushing the device as some obstruction was noted. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10771057
• MDR Text Key: 214133419
• Report Number: 2024168-2020-09105
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/22/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00623U120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial