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 02/12/2018

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 returned for evaluation.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the inability to straighten the steerable guide catheter (sgc).It was reported that during preparation of the sgc, the minus knob was turned and a loud crack was heard.A cable break was suspected.Upon inspection the minus function of the guide appeared to be damaged as the tip was unable to deflect.A new sgc was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated the reported cable break and resultant tip deflection issue (mechanical issue of sgc unable to curve guide) 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 reported from this lot.The investigation determined that the reported noise and mechanical issue of sgc unable to curve guide 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.

• 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: 7313673
• MDR Text Key: 101716644
• Report Number: 2024168-2018-01560
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70629U130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• 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