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

Catalog Number 1012270-20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during unpacking, the balloon of a 2.0 x 20 mm mini trek device fell off.Therefore, it was replaced with another unspecified device to successfully complete the procedure.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub.There was no balloon separation as initially reported.Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other incidents reported from this lot.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

Event Description

Subsequent to the initial report, additional information was received.During preparation, the hypotube of a 2.0 x 20 mm mini trek separated.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial report, additional information was received.During preparation, the hypotube of a 2.0 x 20 mm mini trek separated.The device may have been loaded onto another device that was inside the anatomy.No additional information was provided.

• 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: 7217122
• MDR Text Key: 98352475
• Report Number: 2024168-2018-00570
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012270-20
• Device Lot Number: 70727G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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