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

Catalog Number SGC0101

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the steerable guiding catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during preparation, the stopcock could not be tightened onto the flush port of the steerable guiding catheter (sgc), and if were to reoccur during use, has the potential to leak, which can cause or contribute to patient injury.It was reported that during device preparation of the steerable guiding catheter (sgc), when attempting to connect the stopcock to the flush port, it could not be tightened and continued spinning.The sgc was not used.A new sgc was used without issue.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and based on the reported information and without the device to analyze a cause for the loose connection could not be identified.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: 5830536
• MDR Text Key: 51292661
• Report Number: 2024168-2016-04998
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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: 04/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60413U111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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