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

Catalog Number SGC0301

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The other steerable guide catheter and the clip delivery system are filed under separate medwatch report numbers.

Event Description

This is filed to report the torn steerable guide catheter (sgc 80111u127) soft tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc 80111u124) was advanced into the femoral vein, but resistance was noted. The +/- knob was turned three fourths of a turn to straighten the guide, but the sgc could not be advanced and was removed. It was observed that the sgc tip was not responding in minus direction and a cable break was suspected. A new sgc (80111u127) was advanced successfully. The first clip was implanted, reducing mr to 2. The second clip delivery system (cds 80108u208) was advanced. Visualization and grasping were difficult due to the anatomy. The cds. Was retracted, but became entangled in the chordae. Troubleshooting was performed and the clip was freed. The cds continued to be retracted, but met resistance with the sgc. The cds was pulled hard and a pop was heard. The clip detached from the cds and remained attached to the gripper and lock lines. The clip was caught on the tip of the sgc; therefore, the entire system was retracted together. The clip then caught on the septum. The clip was freed, but the atrial septal defect (asd) was enlarged due to the clip interaction. During removal of the system, resistance was felt with the femoral vein. After removal, it was observed that the sgc soft tip was torn. An asd occluder was used to treat the asd. One clip was implanted, reducing the mr to 2. No additional information was provided.

Manufacturer Narrative

(b)(4). The device was returned for evaluation and the reported steerable guide catheter (sgc) torn soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported tear in the soft tip appears to be related to user technique/procedural conditions as a result of the clip getting caught on the guide tip. Based on the information reviewed, there is no indication of a product quality issue with respect to 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: 7458409
• MDR Text Key: 106742714
• Report Number: 2024168-2018-03043
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/11/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80111U127
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial