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

Catalog Number SGC0302

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced in b5 is filed under separate manufacturer report number.

Event Description

This is being filed to report the resistance felt when removing the clip and clip introducer from the steerable guide catheter, which has potential of injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.While attempting to advance the clip delivery system (cds) clip introducer, resistance was felt with the valve of the steerable guiding catheter (sgc).The clip could be advanced, but the clip introducer could not.When the clip was retracted, resistance was felt between the clip and the clip introducer, which required forceful removal.Both the sgc and cds were replaced.By the end of the procedure, two clips were implanted reducing the mr to less than 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).Evaluation summary: all available information was investigated and the reported difficult clip delivery system (cds) insertion was confirmed; however, the difficult cds removal was not confirmed.The difficult cds insertion was attributed to the tear in the silicone valve; however, a definitive cause for how and when the silicone valve became torn in this incident could not be determined.The returned device analysis confirmed that the cds was able to be removed from the sgc without issue, and a definitive cause for this could not be determined.It is possible that the user technique contributed to the user experience; however, this cannot be confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.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: 6048927
• MDR Text Key: 58207570
• Report Number: 2024168-2016-07197
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: SGC0302
• Device Lot Number: 60727U149
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM