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

Catalog Number SGC0302

Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2019

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 investigation.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 cable break.It was reported that during preparation of the steerable guide catheter (sgc), when turning the +/- knob in the minus direction, a click sound was heard and after that the tip of the guide no longer straightened.A cable break was suspected.The device was not used in the anatomy and was replaced.There was no patient involvement and no reported clinically significant delay in the procedure.A new sgc was used in the procedure without issue.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned and investigated.The reported mechanical issue of unable to curve guide was confirmed and it was observed that the dowel pin had detached from the spool toggle.The analysis was unable to confirm the reported cable break.The reported noise could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation determined the reported mechanical issue appears to be related to the detached dowel pin.The detachment of dowel pin appears to be related to a potential product quality issue.The reported cable break, was likely due to the inability to straighten.The reported noise was likely due to the sound made when the dowel pin detached from the spool.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• 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
• MDR Report Key: 8709564
• MDR Text Key: 148406651
• Report Number: 2024168-2019-04826
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90309U117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1