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

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned and investigated.The reported leak was confirmed via returned device analysis.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 similar complaints reported from this lot.The investigation determined the reported leak is a potential product issue.Therefore, an exception (issue) was initiated to evaluate whether a product issue exists.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

This is being filed to report a loss of fluid column in the steerable guide catheter hemostatic valve during device preparation.It was reported that during preparation of the steerable guide catheter (sgc) the hemostatic valve would not hold fluid column.The sgc was not used.There was no clinically significant delay to the intended procedure and no patient involvement.No additional information was provided regarding this device issue.

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.

Manufacturer Narrative

All available information was investigated, and the reported leak was confirmed via returned device analysis.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 similar complaints reported from this lot.The investigation determined the reported leak/splash appears to be related to the failure to bond between the proximal and distal shaft.The failure to bond on the shaft 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.H6: component code 4721 added.H10: additional manufacturing narrative updated.

• 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: 12965230
• MDR Text Key: 283933456
• Report Number: 2024168-2021-11297
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10716R144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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