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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The clip delivery system referenced in b5 and d11 is reported under a separate medwatch report number.

Event Description

This event is filed for damage to the soft tip of the steerable guide catheter, which has the potential to cause or contribute to patient injury.It was reported that on (b)(6) 2016, the patient underwent an unproctored procedure to treat tricuspid regurgitation.During the procedure, three mitraclips were implanted, connecting the anterior and septal leaflets.During use of the 4th clip delivery system (cds), the clip was unable to grasp the leaflet and was removed; however, during removal, the clip got caught on the soft tip of the steerable guide catheter (sgc).The physician was not aware that the clip was caught and force was applied during removal.The clip detached from the cds, but was still attached to the gripper lines.The detached clip, gripper lines, cds and sgc were removed as a single unit.Upon removal, it was noted that the soft tip of the sgc was torn.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the reported damage to the soft tip was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.The cine from the procedure was provided and reviewed by an abbott vascular senior medical advisor.The reviewer noted that the interaction between the steerable guide catheter (sgc) soft tip and clip delivery system (cds) could be seen on images, thus confirming the reported event and damage observed to the soft tip during returned device analysis.The removal of the devices as a single unit was seen and there was no evidence of detachment of a portion of the soft tip during interaction between the clip and the sgc.The reviewer also noted that no device issue was noted in any of the images provided.All available information was investigated and the reported damage to the soft tip (tear and soft tip material detachment) appears to be related to user technique/procedural conditions, as it was a secondary effect to the clip becoming caught on the tip and retracted with force.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, return device analysis noted that the steerable guide catheter was returned with the soft tip torn and separated.

• 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: 5626024
• MDR Text Key: 44464818
• Report Number: 2024168-2016-02796
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60104U103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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