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 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guiding catheter was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other steerable guide catheter(60307u107) referenced is filed under a separate medwatch report number.

Event Description

This report is filed for the inability to connect devices to the flush port(60307u111).Although there was no patient involvement, if this were to recur in the anatomy, there is a potential to cause or contribute to patient injury.It was reported that during preparation of the first steerable guiding catheter (sgc 60307u111), the stopcock was connected to the sgc flush port, but would unwind and not tighten.Multiple stopcocks were used, but would not tighten onto the flush port.The device was not used in the patient and was replaced.A new sgc (60307u107) was un-packaged and a stopcock was connected.The devices appeared to be secure and preparation was started, but the fluid column was lost.The stopcock was found to be loose; therefore, the decision was made to use a needle free valve as a connection between the stopcock and the flush port.The sgc was then used to complete the procedure without issue.There were no adverse patient effects or clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device returned for analysis.The reported loose connection was unable to be confirmed as proxy stopcocks were able to thread onto the steerable guide catheter (sgc) stopcock flush port.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not identify a lot-specific quality issue.All available information was investigated and a definitive cause for the reported loose connection could not be determined.It is possible there is variation in the non-abbott stopcocks used during the procedure, which likely contributed to the reported loose connection; however, this cannot be definitively confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 5800211
• MDR Text Key: 50228941
• Report Number: 2024168-2016-04651
• 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: 08/03/2016

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: 03/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60307U111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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