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 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned and investigated.The reported cable break and mechanical issue of steerable guide catheter (sgc) unable to curve guide were confirmed.The reported noise (device operates differently than expected) could not be replicated in the testing environment as the event was a symptom of the cable break.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the information reviewed, the noise and mechanical issue was due to the cable break; however, a definitive cause for the cable break could not be definitely determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

This report is filed for the suspected cable break.It was reported that after device preparation, but before use, the plus/minus knob was turned half a turn in the minus direction to straighten the tip of the steerable guide catheter (sgc) to insert into the patient, but a noise was heard and the tip did not respond to the knob being turned.A cable break was suspected.Another sgc was used to complete the procedure.No additional information was provided.

• 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: 6630332
• MDR Text Key: 77451662
• Report Number: 2024168-2017-04929
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216831
• UDI-Public: (01)08717648216831(17)180224(10)70224U136
• 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
• Report Date: 06/09/2017

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: 02/24/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70224U136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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