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

Catalog Number SGC0702

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak and break on the device.It was reported that during device preparation of the steerable guide catheter (sgc), the dilator was not tight and water came out of the connection between the rotating hemostatic valve and the dilator.The connection was further examined and it was found to be broken.The sgc assembly was exchanged, and the procedure was completed without further reported complication.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Event Description

This is filed to report a leak and break on the device.It was reported that during device preparation of the steerable guide catheter (sgc), the dilator was not tight and water came out of the connection between the rotating hemostatic valve and the dilator.The connection was further examined and it was found to be broken.The sgc assembly was exchanged, and the procedure was completed without further reported complication.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

The return device analysis confirmed the dilator y connector broke off from the dilator shaft.However, the reported leak could not be tested due to the returned condition.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 reported from this lot.Based on available information and return device analysis, the reported leak and break appear to be related to a potential product quality issue.Therefore, exception (issue), exception (action) via exception (subtask) has been raised on 03/29/2023 for further investigation of a potential product issue.Abbott will continue to trend the performance of these devices.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

Event Description

N/a.

Manufacturer Narrative

The return device analysis confirmed the dilator y connector broke off from the dilator shaft.However, the reported leak could not be tested due to the returned condition.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 reported from this lot.Based on available information and return device analysis, the reported leak and break appear to be related to a potential product quality issue.Therefore, an exception (action) has been raised on (b)(6) 2023 for further investigation of a potential product issue.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 MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16590723
• MDR Text Key: 312126140
• Report Number: 2135147-2023-01288
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

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: 09/27/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20927R3017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 04/26/2023
• Supplement Dates FDA Received: 04/21/2023; 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1