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

Catalog Number SGC0302

Device Problem Break (1069)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/13/2017

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 the steerable guide catheter (sgc) cable break.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 3-4.When attempting to cross to the septum with the sgc, slight resistance was felt due to the anatomy.When turning the +/- knob to straighten the guide, a "ping" sound was heard and the tip was no longer responding.A cable break occurred.The sgc was removed and was replaced.One clip was implanted reducing mr to <1.There were no adverse patient effects.The patient is well.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned.All available information was investigated the reported cable break and resultant tip deflection issue 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.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents from the 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.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed report, the following information was provided.The reported slight resistance felt during advancement was not more than usual.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: 7072257
• MDR Text Key: 93703027
• Report Number: 2024168-2017-09283
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70622U213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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: 75 YR
• Patient Weight: 88