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

Catalog Number 1012272-15

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2016, the patient, who was scheduled for a coronary artery bypass graft (cabg) procedure, underwent a coronary procedure to treat a heavily calcified lesion in the mid circumflex (cx) artery.An unspecified guide wire was placed with difficulty in the mid cx.Pre-dilatation was performed at the proximal portion of the lesion, using an unspecified trek dilatation catheter.The 2.5 x 15 mm trek dilatation catheter was advanced to the distal portion of the lesion.The trek dilatation catheter balloon was inflated to 24 atmospheres for 49 seconds and a balloon rupture occurred.A portion of the balloon separated, with a segment of the balloon remaining in the patient anatomy.No attempt was made to retrieve the balloon segment.Although a cabg procedure had been planned, the patient was sent for cabg to remove the separated balloon segment.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The trek rx instructions for use warns: balloon pressure should not exceed the rated burst pressure (rbp).Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 5527047
• MDR Text Key: 41189354
• Report Number: 2024168-2016-01947
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 51112G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention; Disability
• Patient Age: 68 YR