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

Catalog Number 1012268-06

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The hi-torque whisper ms referenced is being filed under a separate medwatch mfr number.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 the procedure was to treat a heavily calcified, heavily tortuous, 99% stenosed concentric de novo lesion in the left anterior descending artery.Resistance was felt during advancement of the whisper guide wire due to the patient anatomy.A non-abbott microcatheter was used for support, and the guide wire crossed the target lesion.Due to the challenging patient anatomy, attempts were made to dilate the lesion by applying torque to the microcatheter.The microcatheter got stuck with the lesion and was replaced with another microcatheter and the lesion was dilated.The microcatheter was removed and a 1.20x6 mm trek rx balloon dilatation catheter (bdc) was advanced over the whisper guide wire; however, resistance was met between the guide wire and the inner member of the trek bdc.After the trek bdc exited the tip of the guiding catheter, the guide wire and the bdc were stuck.The guide wire was held firmly, and an attempt was made to advance the trek bdc only, by pushing the bdc but the guide wire also advanced with the trek bdc.The guide wire and the trek bdc were advanced together and balloon dilatation was performed without issues.An attempt was made to remove the trek bdc, but resistance was met between the guide wire and the trek bdc until the balloon catheter was pulled into the guiding catheter.Then, no further resistance was encountered between the guide wire and the trek bdc.The trek bdc was removed from the anatomy by itself.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation.The reported difficulties could not be confirmed.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation was unable to determine a conclusive cause for the reported difficulties.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history of the reported lot revealed no other incidents reported for difficult to position or difficult to remove.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 5496343
• MDR Text Key: 40263536
• Report Number: 2024168-2016-01561
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012268-06
• Device Lot Number: 50409G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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