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

Catalog Number SGC0302

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.All available information was investigated and the and the reported difficult to advance was confirmed due to the observed torn silicone valve of the steerable guide catheter (sgc).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 incidents reported from this lot.All available information was investigated and based on the result of the returned device analysis, the reported difficulty advancing the clip delivery system (cds) into the sgc appears to be due to the observed torn sgc silicone valve.The torn silicone valve was likely due to the user technique of cds insertion/advancement.There is no indication of a product issue with respect to manufacture, design or labeling.The additional cds referenced is being filed under a separate medwatch report number.

Event Description

This is being filed to report the torn silicone valve noted on the returned steerable guide catheter.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) met resistance during advancement in the steerable guide catheter (sgc).The cds was advanced and an attempt was made to open the clip when it detached from the delivery catheter (dc) but still remained on the gripper lines.The cds was pulled back however the clip totally detached and remains in the iliac vein.One clip was able to be implanted, reducing mr to 1.No additional information was provided.Subsequent to the initially filed medwatch, return analysis noted the sgc silicone valve was torn.No additional information was provided.

• 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: 9506152
• MDR Text Key: 178336073
• Report Number: 2024168-2019-14862
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90507U107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• 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