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

Catalog Number SGC0302

Device Problems Break (1069); Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

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 is filed to report a cable break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3.When attempting to insert the steerable guide catheter (sgc) into the anatomy, entering the vein was difficult so negative pressure was applied on the sgc.A snap sound was heard and the knob stopped working.It turned freely with no effect on the tip of the sgc.A cable break was suspected.No excessive force was used when turning the knob and it could not be confirmed if the knob was overturned.A new sgc was used to complete the case.The final mr grade was <1.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported cable break and resulting steerable guide catheter unable to curve were confirmed via returned device analysis.The reported noise could not be replicated in the testing environment as the event was a symptom of the cable break.Additionally, the reported difficulty inserting the guide into the anatomy could not be replicated in a testing environment as it was related to the patient/procedural conditions (operational circumstances).A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined that the reported noise and mechanical issue of inability to deflect the tip were a result of the cable break; however, a definitive cause for the cable break could not be definitively determined.The investigation was also unable to determine a definitive cause for the reported difficulty inserting the guide into the anatomy.Based on the information reviewed, 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
• 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: 7031433
• MDR Text Key: 93059574
• Report Number: 2024168-2017-08967
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70713U112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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