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

Catalog Number SGC0301

Device Problems Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

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 relevant information.

Event Description

This report is filed due to the suspected steerable guide catheter cable break.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (mr) grade 4.The steerable guide catheter (sgc) was advanced to the left atrium.The sgc +/- knob was turned negative, approximately 1/2 a turn, when a pop was heard.There was no sgc tip deflection following and a cable break was suspected.The device was removed without reported issue and another sgc was used in replacement.One mitraclip was implanted and the mr was reduced to trace or <1.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this device issue.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported mechanical issue and cable break were confirmed.The reported device operating differently than expected (noise) could not be replicated in a testing environment as it was likely a symptom of cable break and a cascading effect.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported cable break in this incident cannot be determined.It is possible that there were procedural interactions (e.G.Unintended/excessive curves on the device) which resulted in increased tension on the device and therefore contributed to the cable break; however, this cannot be confirmed.The reported mechanical issue and device operating differently than expected (noise) appears to be related to the cable break.Lastly, the observed kinked steerable guide catheter (sgc) shaft appears to be related to user technique/procedural conditions; however, this cannot be definitively confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was obtained: two mitraclips were successfully implanted without a reported device malfunction, reducing mitral regurgitation to trace.

• 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: 7045288
• MDR Text Key: 93318777
• Report Number: 2024168-2017-09079
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70804U152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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
• Patient Age: 78 YR
• Patient Weight: 89