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 06/21/2019

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 device was discarded.A follow-up report will be submitted with all additional relevant information.The clip referenced is being filed under a separate medwatch report.

Event Description

This is filed to report during withdrawal of the cds, the clip got caught with the sgc tip and damaged the soft tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips implanted successfully, reducing mr to 2.A third clip delivery system (cds) was advanced to the mitral valve to further reduce mr.The clip was placed but mr reduction was not adequate for the clip to be used.Therefore, it was decided to not deploy the clip, the clip was closed and retracted into the steerable guide catheter (sgc).However, the clip arms got caught with sgc tip.The cds was advanced to left atrium and the clip was rotated.The clip was able to be retracted into the sgc, but the sgcs tip was damaged (torn).There were no other issues with the devices.Both cds and sgc were removed from the patients anatomy successfully.Two clips implanted, reducing mr to 2.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 that would have contributed to reported event.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported torn steerable guide catheter (sgc) tip appears to be related to procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-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.

• 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: 8790581
• MDR Text Key: 151130563
• Report Number: 2024168-2019-10076
• 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: 04/24/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90424U119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMLPLANTED MITRACLIPS; CLIP DELIVERY SYSTEM
• Patient Age: 84 YR
• Patient Weight: 80