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

Catalog Number SGC0301

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the sgc was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate medwatch report number.

Event Description

This is being filed to report the sgc soft tip became torn when the clip got caught during removal.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade of 4.During the procedure, visibility was bad.The clip delivery system (cds) was advanced to the mitral valve but visibility was bad due to the transseptal puncture location and equipment and it was decided to redo the transseptal puncture.Therefore, it was decided to remove the cds.During removal of the cds, the clip became stuck with the steerable guide catheter (sgc) tip; therefore, both devices were removed from the patient anatomy together.Outside the patient anatomy it was noted that the sgc soft tip became torn.A new sgc and cds were used to successfully reducing mr to 1.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified 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 the reported soft tip tear and poor image resolution appears to be related to the user technique/procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8807716
• MDR Text Key: 151625208
• Report Number: 2024168-2019-10189
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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: 03/13/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90313U257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Age: 79 YR