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

Catalog Number SGC0302

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other additional device referenced are being filed under a separate medwatch report number.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.

Event Description

This is being filed to report the tear in the sgc tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The clip delivery system (cds) was advanced to the atrium and the arm positioner was rotated however the clip arms would not close.Troubleshooting was performed however was unsuccessful therefore the clip was inverted and the cds was attempted to be retracted through the steerable guide catheter (sgc).Resistance was met therefore force was applied, resulting in the tip of the sgc tearing.The cds and sgc were removed together.Another sgc and cds were used, and the clip was implanted, reducing the mr to 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

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 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 torn steerable guide catheter (sgc) soft tip appears to be related to user technique/procedural conditions.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
• MDR Report Key: 8989956
• MDR Text Key: 157399076
• Report Number: 2024168-2019-11674
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90611U252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM