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

Catalog Number SGC0101

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2016

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 relevant information.

Event Description

This event is filed for a leak in the device, which, if used, has the potential to cause or contribute to patient injury.It was reported that during preparation of the steerable guide catheter (sgc), the device would not hold the fluid column and bubbles were seen in the device.The device was re-prepped for use three times, which included switching out the stopcocks and making sure that all connections were tight, but the bubbles remained.The device was not used and there was no patient involvement.A second sgc was then prepared for use without difficulty.Two mitraclips were implanted and the mitral regurgitation (mr) was reduced from grade 4+ to grade 1+.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported steerable guide catheter (sgc) was checked for leaks, but no leak was found; thus, the reported leak was not confirmed.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 a definitive cause for the reported sgc leak could not be determined.It is possible that the user technique during device preparation contributed to the reported leak; however, this cannot be definitively confirmed.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: 6048997
• MDR Text Key: 58508647
• Report Number: 2024168-2016-07199
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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: 10/27/2016

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: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60630U106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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