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 06/22/2016

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the leak from the loose cap on the steerable guide catheter (sgc) which if used has the potential to cause or contribute to patient injury.It was reported that during preparation of the sgc, when the tip of the guide was submerged in the basin, the fluid column was lost.The system was checked and it was found that the cap of the dilator was loose.The cap was re-tightened and preparation was performed again, but leaking was observed at the dilator cap.The cap was checked and confirmed to be tight, but continued to leak.The decision was made to replace the device.There was no patient involvement, and a new sgc was used successfully.No additional information was provided.

Manufacturer Narrative

(b)(4).The complaint device was returned and a leak was confirmed due to a missing o-ring.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.A review of the complaint history identified no similar incident for leaks.An expanded review was conducted that identified an issue potentially related to manufacturing.Further assessment of this issue per site operating procedures was performed.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: 5802422
• MDR Text Key: 50180841
• Report Number: 2024168-2016-04687
• 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: 09/26/2016

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: 60409U125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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