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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter 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 filed under a separate medwatch mfr number.

Event Description

This report is filed for the soft tip damage which has potential to cause or contribute to serious injury.It was reported that the inter-atrial septum wall was very thick and the trans-septal puncture (tsp) was too anterior.While advancing the mitraclip steerable guide catheter (sgc) and the clip delivery system (cds) through the tsp, there was an awkward trajectory and the cds was too anterior and too close to the aorta.It was decided to remove the cds, but during removal, the clip got caught on the sgc soft tip.Troubleshooting was performed and the clip was able to be removed from the sgc.After removal, the soft tip of the sgc was noted to be damaged and torn.Zero clips were implanted and the mitral regurgitation (mr) remained 4+.There were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.Based on the case information reviewed, the reported steerable guide catheter soft tip tear appears to be related to procedural conditions due to the clip becoming caught on the soft tip during removal and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5677184
• MDR Text Key: 45871838
• Report Number: 2024168-2016-03380
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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: 12/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 51203U102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 74 YR
• Patient Weight: 61