MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER

Catalog Number 1012270-12

Device Problems Leak/Splash (1354); Physical Property Issue (3008); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional inspections were performed on the returned device.The reported physical property issue (unsmooth area) was confirmed as a tear/leak in the guide wire exit notch was noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported complaint and noted issues appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

Event Description

It was reported that during a procedure of the coronary vessel the mini trek balloon dilatation catheter (bdc) was prepared for use and during insertion over the guide wire the area of the hypotube shaft transition was not smooth.The device was removed and not used.There was no reported adverse patient effect.A different device was used in the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.Returned device analysis noted a tear and leak at the guide wire exit notch.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7226678
• MDR Text Key: 98645534
• Report Number: 2024168-2018-00667
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138140
• UDI-Public: 08717648138140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1012270-12
• Device Lot Number: 70515G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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