MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 soft tip damage.It was reported that during preparation of a steerable guide catheter (sgc), the white tip shape retainer was removed with resistance and visual inspection was performed; however, it was then observed that the tip looked deformed.The tip seemed fractured and dented in an angle.The sgc was not used in the patient and the procedure continued with a new sgc.There was no patient involvement and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported deformation due to compressive stress was confirmed as the steerable guide catheter (sgc) shaft was observed to be deformed.The reported difficult to remove was not confirmed using a proxy white guide tip shape retainer and transparent protective tubing.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in the issue.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and a definitive cause for the reported deformation due to compressive stress cannot be determined; however, the reported difficult to remove was likely an cascading effect of deformation of the shaft.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 9776598
• MDR Text Key: 181737496
• Report Number: 2024168-2020-01919
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

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: 05/23/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90523U134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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