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

Catalog Number 1012268-06

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that during treatment of a heavily tortuous and heavily calcified right coronary artery with 100% in-stent restenosis, reportedly, after a non-abbott balloon dilatation catheter (bdc) was unable to cross the stenosis, a rx mini trek 1.20x6mm bdc was advanced and able to cross the stenosis.The rx mini trek 1.20x6mm bdc inflated five times.When the mini trek rx bdc was removed, the guide wire came with it.A guide wire was advanced to the lesion and an attempt was made to cross the lesion with a non-abbott bdc, but it could not cross the lesion.The same rx mini trek 1.20x6mm bdc was advanced for the second time, but became caught up in the anatomy, proximal to the lesion.The rx mini trek 1.20x6mm bdc could not cross the lesion.Another guide wire was inserted and another attempt was made to cross the lesion with the rx mini trek 1.20x6mm bdc, but was unsuccessful.It was believed that the dilatation catheter balloon was not properly rewrapped causing the inability to cross the lesion when advanced in the vessel a second time.A non-abbott 1.0mm bdc was able to cross the lesion and a stent was implanted.There were no reported adverse patient sequelae and no reported significant clinical delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: asahi fielder xt-a, asahi fielder xt-r, asahi gaia.It is indicated that the device was discarded and is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the lot history record revealed no non-conformances related to the reported event.Results of the query of similar incidents in the complaint-handling database from this lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3803218
• MDR Text Key: 4368219
• Report Number: 2024168-2014-02978
• Device Sequence Number: 1
• Product Code: LOX
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 1012268-06
• Device Lot Number: 20516G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Age: 72 YR
• Patient Weight: 80