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 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The sgc was returned and investigated and was noted to have a torn soft tip. 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 identified no similar incidents reported from this lot. The returned device analysis confirmed tears in the soft tip which is indicative of an interaction between the clip and guide tip during retraction. All available information was investigated and a definitive cause for the identified tears in the soft tip could not be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The clip delivery system was filed under mfr report # 2024168-2017-05691.

Event Description

This is filed to report the steerable guide catheter (sgc) soft tip tear. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. Two clips were implanted without issue, reducing the mr to moderate. The third clip delivery system (cds) was advanced for lateral placement, close to the commissure. The leaflets were successfully grasped, but the clip failed to deploy. The decision was made to remove the cds with the clip. While retracting the clip into the sgc, the clip detached from the cds, inside the sgc. There was no resistance noted within the sgc, and the clip was successfully removed with the cds. Two clips were implanted, reducing the mr to 3. The patient was confirmed to be stable post procedure. There was no clinically significant delay in the procedure. Returned device analysis found that the sgc soft tip was torn. No additional information was provided.

• 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: 6982113
• MDR Text Key: 91091411
• Report Number: 2024168-2017-08500
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 61003U201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial