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

Catalog Number 1012272-15

Device Problems Inflation Problem (1310); Kinked (1339); Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

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 not returned for evaluation.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 difficulties appear to be related to circumstances of the procedure.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 the procedure was to treat a de novo lesion located in the proximal posterior lateral coronary artery that was mildly tortuous, mildly calcified and 80% stenosed.The nc trek 2.5 x 15 mm balloon dilatation catheter (bdc) was advanced in the anatomy with resistance and inflated to 10 atmospheres but the balloon could not expand further.When the bdc was removed from the anatomy, the balloon tip was kinked and the balloon was ruptured.Another non-abbott balloon was used to successfully pre-dilate the lesion and complete the procedure.It was confirmed that the device was prepped per the instructions for use with no leak noted during preparation.There were no adverse patient effects or clinically significant delay.No additional information was provided.

• Brand Name: 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: 6730534
• MDR Text Key: 80699435
• Report Number: 2024168-2017-06073
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: 08717648138294
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1012272-15
• Device Lot Number: 51103G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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
• Patient Age: 79 YR
• Patient Weight: 74