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

Catalog Number SGC01ST

Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

This event is being filed because the clip delivery system (cds) was returned with what appears to be a piece of the steerable guide catheter (sgc) soft tip material on it, suggesting that the sgc soft tip was torn as a result of the resistance noted during the procedure.A torn tip has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.Difficulty was noted during use of the m-knob; however, the clip delivery system (cds) was able to be positioned in the small left atrium.However, once the cds was in the left atrium, the clip was unable to open.During removal of the cds, resistance was met with the tip of the steerable guide catheter (sgc).Reportedly, the sgc was not straightened prior to removal of the cds.The cds was able to be removed from the sgc after two to three attempts and troubleshooting.Four clips were deployed and the procedure was completed successfully, reducing mr to 1-2, with no adverse patient effects, and no clinically significant delay in the procedure.There was no additional information provided.The cds was returned with what appears to be a piece of the sgc soft tip material on it, suggesting that the sgc soft tip was torn as a result of the resistance noted during the procedure.

Manufacturer Narrative

(b)(4).The steerable guide catheter (sgc) was not returned for analysis; however, the analysis of the returned clip delivery system (cds) associated with this complaint identified a piece of transparent material resembling the sgc soft tip, which is indicative of the clip getting caught and damaging the sgc tip.A review of the lot history record identified no manufacturing nonconformities.A query of the electronic complaint handling database revealed no other incidents reported for this lot.It should be noted that the mitraclip instructions for use (ifu) warns: failure to straighten the sgc prior to retracting the clip into the sgc may result in device damage, inability to remove the cds, and/or vascular and cardiac injury.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The clip delivery system (cds) referenced is being filed under a separate medwatch mfr number.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4854248
• MDR Text Key: 5808703
• Report Number: 2024168-2015-03385
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50206U320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Treatment: OTHER: CLIP DELIVERY SYSTEM (CDS)