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

Catalog Number SGC0101

Device Problems Loss of or Failure to Bond (1068); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 based on returned device analysis that found the hemostasis valve bond was broken, which has the potential to cause a leak resulting in air being introduced into the patient.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 3.The clip delivery system (cds) was attempted to be inserted into the steerable guiding catheter (sgc); however, the cds could not be inserted past the sgc keyway.The blue alignment lines were confirmed to be aligned.Three attempts were made and then the sgc was removed and replaced.The same cds was used in the new sgc without issue.It was confirmed that all steps were performed per the instructions for use during preparation of the devices and during the procedure.One clip was implanted, reducing the mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Subsequent, preliminary analysis of the returned device found that the sgc hemostasis valve bond was broken.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The steerable guide catheter (sgc)was returned with evidence of usage.The valve was dissembled and the bond between the valve and sgc was examined; it was confirmed that the bond was broken between the adhesive and the pebax.Based on the results of the investigation, it was determined the loose rotating hemostatic valve (rhv) may be related to inherent variability during manufacturing.A review of the complaint handling database found no other similar incidents from this lot for detachment.The lot history record was reviewed and identified no manufacturing nonconformities that were related to detachment.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: 5520574
• MDR Text Key: 41066639
• Report Number: 2024168-2016-01856
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 51013U148
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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