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

Catalog Number SGC0101

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guiding catheter was received.The 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 of the steerable guiding catheter (sgc), the hemostasis valve of the dilator was leaking and would not remain tightened.If this were to reoccur in the anatomy, a leak has the potential compromise the fluid path integrity and lead to an air embolism.It was reported that during preparation of the steerable guiding catheter (sgc), the dilator began to be inserted into the sgc but a leak was observed at the rotating hemostasis valve (rhv) of the dilator.The rhv was tightened, but would not remain tight and began to leak again.All devices were outside the anatomy.There was no patient involvement.The decision was made to replace the dilator.A new device was used without issue.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The complaint device was returned and the reported leak and loose rotating hemostatic valve (rhv) cap were not confirmed via returned device analysis.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified two similar incidents for dilator leak.The potential cause of the dilator leak was determined to be a misaligned silicone seal in the rhv.Further assessment of this issue was performed and corrective and preventative actions to address it are in the process of being implemented.Additionally, the performance of these devices will continue to be monitored.

• 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: 5231600
• MDR Text Key: 31576981
• Report Number: 2024168-2015-06947
• 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: 12/17/2015

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: 06/30/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 506509U217
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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