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

Catalog Number 1012270-20

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

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: visual and functional inspections were performed on the returned device.The reported cracks were confirmed; however, the reported loose or intermittent connection could not be confirmed.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 was unable to determine a conclusive cause for the reported loose or intermittent connection; however, the reported cracks 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 a 2.0x20mm mini trek dilatation catheter was advanced to the proximal left anterior descending (lad), 75% stenosed lesion without issue.The mini trek was unable to connect to an unspecified indeflator.It was then noted that the mini trek hub cracked.There was no leakage or air entrapment noted.The mini trek was removed from the anatomy without reported issue and a new device was used successfully with the same indeflator.The procedure was completed successfully.There were no adverse patient effects and there was no clinically significant delay.There were no other device issues.There was no additional information provided regarding this device.During abbott vascular's analysis of the returned mini trek, the device was securely attached to a proxy indeflator and an attempt was made to pressurize the balloon catheter to balloon nominal pressure of 8 atmospheres, when fluid leaked out of the cracks noted in the hub and the balloon could not be inflated.

• 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: 6519472
• MDR Text Key: 73851897
• Report Number: 2024168-2017-03575
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138164
• UDI-Public: (01)08717648138164(17)191130(10)61201G1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1012270-20
• Device Lot Number: 61201G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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