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

Catalog Number 1012274-15

Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed on the returned device.The reported loose or intermittent connection was confirmed.In this case, it is possible that the inflation device was over torqued/tightened during connection to the hub of the device, resulting in the crack in the hub and subsequent leaking; however this cannon be confirmed.Additionally, the guide wire exit notch was torn distally.The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacturing, or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified lesion in the left anterior descending coronary artery.Reportedly, the 3.00 x 15 mm trek rx was at the target lesion; however, when an attempt to dilate the balloon with a manometer was made the contrast media sprayed out of the connection between the trek rx and manometer.A second manometer was used to again try to dilate the balloon with the same result.No contrast reached the balloon.Both manometers were used with other balloons and stent successfully.The procedure was successfully completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.No additionally information was provided.Return device analysis revealed the shaft was torn at the guide wire exit notch.

• 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: 6215685
• MDR Text Key: 63825004
• Report Number: 2024168-2016-09388
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138430
• UDI-Public: (01)08717648138430(17)181031(10)51111G1
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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: 1012274-15
• Device Lot Number: 51111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• 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