MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0301

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 two clip delivery systems are filed under separate medwatch reports.

Event Description

This is being filed to report the torn steerable guide catheter (sgc) soft tip.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr), with an mr grade of 4.The sgc was inserted and the clip delivery system (cds 80316u196) was advanced.Visualization was difficult due to the anatomy.When applying m-knob, the shaft kept going in the opposite direction.The clip was not implanted.When retracting the cds, resistance was felt with the sgc.The cds was removed from the sgc without causing damage to the sgc.A second cds (80316u252) was inserted into the same sgc, when m-knob was applied; the shaft went in the opposite direction, not towards the valve.The clip was not implanted.When retracting the cds, one of the grippers got caught on the tip of the sgc and tore the sgc soft tip.The cds and sgc were removed separately without further issues.The procedure was discontinued.No clips were implanted, and the mr remains at 4.There were no adverse patient effects and no clinically significant delay during the procedure.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4).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 a definitive cause for the reported difficulty removing the device in this incident could not be determined.The reported soft tip tear is a cascading effect/procedural conditions (grippers got caught on the tip of the sgc).The reported poor image resolution appears to be related to the difficulty in visualization during the procedure due to the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7682781
• MDR Text Key: 114033578
• Report Number: 2024168-2018-05313
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80206U136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP DELIVERY SYSTEM