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 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: mitraclip system, steerable guide catheter, 1 implanted mitraclip.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 (b)(4) referenced is filed under a separate medwatch report number.

Event Description

This is filed to report that after the steerable guiding catheter (sgc) was removed from the anatomy, it was found that the soft tip was torn, which has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.The patient was in cardiogenic shock 2 days prior to the procedure; therefore, was placed on a balloon pump and this case was urgently planned.One clip was implanted in the medial segment, reducing the mr to 3+.Grasping was noted to be difficult due to the anatomy.The second clip delivery system (cds) was advanced and slightly under-straddled due to the small left atrium.The cds was then inadvertently pulled too far back and became stuck on the tip of the steerable guiding catheter (sgc).Troubleshooting was performed to separate the devices, but was unsuccessful; therefore, the cds and the sgc were removed as a single unit from the anatomy.After removal, the clip was removed from the sgc tip and it was found that a piece of the sgc tip was torn and remained in the clip.Nothing was left in the anatomy.No further clips were attempted and the procedure was discontinued.The patient remained hemodynamically stable throughout the procedure and was confirmed to be stable post-procedure, with no clinically significant delay.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 other incidents reported for soft tip tears from this lot.All available information was investigated and the tears in the soft tip appear to be related to procedural conditions due to the clip becoming caught on the tip.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing 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: 5944146
• MDR Text Key: 54784493
• Report Number: 2024168-2016-06032
• 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: 10/03/2016

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: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60603U103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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: 79 YR
• Patient Weight: 80