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 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter (sgc) was returned and the reported cable break and inability to curve the guide were confirmed.The reported noise was unable to be tested.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.The investigation was unable to determine a conclusive cause for the sgc cable break; however, it was determined that the cable break resulted in the inability to curve the guide and noise.It is possible that there were procedural interactions (e.G.Excessive knob turning and unintended curves on the device) which resulted in over-tensioning of the cables such that the cable broke; however, this cannot be definitively confirmed.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

This is filed to report the suspected cable break.It was reported that during preparation of the steerable guide catheter (sgc) when turning the +/- knob in the minus direction, a loud cracking sound was heard and after that, the tip of the guide no longer responded.A cable break was suspected.The device was not used in the anatomy, and was replaced.A new sgc was used without issue.There was no clinically significant delay in 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: 6540847
• MDR Text Key: 74488305
• Report Number: 2024168-2017-03853
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216831
• UDI-Public: (01)08717648216831(17)180103(10)70103U126
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70103U126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• 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