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

Catalog Number SGC0302

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

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the loss of tip deflection.It was reported that on (b)(6) 2017, the patient, with mixed etiology mitral regurgitation (mr), underwent a mitraclip procedure.During preparation of the steerable guide catheter (sgc), the "-" knob was tested, per instructions for use (ifu), and a noise was heard.There was a loss of tip deflection when the "-" knob was turned.A cable break was suspected.The device was not used and there was no patient involvement.A new sgc was prepared and one mitraclip was implanted.The mr was reduced from grade 4 to <1.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter was returned and the reported mechanical issue and cable break was confirmed.The reported 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 during preparation) 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 noise appears to be a result of cable break.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• 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: 6472888
• MDR Text Key: 72403650
• Report Number: 2024168-2017-02924
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/17/2017

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: 01/04/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70104U110
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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