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

Catalog Number SGC01ST

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2016

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.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is filed fo the hemostatic valve that was unable to connect to the flush port during device preparation.Although there was no patient involvement, if this were to recur in the anatomy, there is potential for a leak which can cause or contribute to patient injury.It was reported that during steerable guide catheter device preparation, the dilator rotating hemostatic valve was unable to connect to the flush port.The device was set aside for return.There was no patient involvement.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device returned for analysis and the reported dilator cap detachment was confirmed.The reported unstable cap was not confirmed as it was able to be snapped back onto the rotating hemostatic valve (rhv) and remained on.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 other incidents reported from this lot.All available information was investigated and the reported unstable and detachment of the dilator cap appears to be related to user technique as it was reported that the physician disconnected the cap and did not know how to reconnect it.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous medwatch report, additional information was obtained that the dilator cap was disconnected from the rotating hemostatic valve (rhv) by the physician.There was no issue noted with the rotating hemostatic valve.

• 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: 5784424
• MDR Text Key: 49286230
• Report Number: 2024168-2016-04510
• 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: 08/15/2016

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: 02/28/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60223U135
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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