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

Catalog Number SGC0301

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2018

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 additional relevant information.

Event Description

This is filed to report the cable break.It was reported that during device preparation of the steerable guide catheter (sgc), while testing the +/- knob, when the knob was turned a 1/2 turn in the minus direction, a loud noise sounded and it was suspected that the cable broke.There was no patient involvement.Another sgc was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The returned device analysis could not confirm the cable break.The device functioned as intended with both cables responding appropriately to the plus/minus knobs.The reported device operated differently than expected (noise) could not be replicated in a testing environment as it was likely a symptom of the cable break and a cascading effect.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to the reported event.Review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the suspected cable break could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7866425
• MDR Text Key: 119929212
• Report Number: 2024168-2018-07084
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80416U117
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1