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

Catalog Number	1012405-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Concomitant medical products: guide wire: sion blue, guiding catheter: launcher.The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It was reported that the device was prepared for use by performing an air aspiration inside of the anatomy.It should be noted that the trek over the wire (otw) and mini trek otw, coronary dilatation catheters (cdc), global, instruction for use (ifu) specifies: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.All air must be removed from the balloon and displaced with contrast prior to inserting into the body.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.
Event or Problem Description
It was reported that during the procedure to treat a concentric, heavily calcified, 90% stenosed, 3.0x28mm, de novo lesion in the moderately tortuous mid left anterior descending (lad) coronary artery, after unpackaging the device without issue and after prepping the device via air aspiration inside of patient anatomy, the 2.5x15mm trek otw balloon dilatation catheter (bdc) was advanced to the lesion without resistance.During the first inflation, the balloon ruptured at 7 atmospheres (atm) at 1 second.The bdc was withdrawn without resistance.The device was replaced with an nc trek 2.5x15mm bdc.The procedure was successfully completed after a xience alpine 3.0x28mm stent was implanted, resulting in 0% lesion stenosis.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6133666
• Report Number: 2024168-2016-08408
• Device Sequence Number: 1129271
• Product Code: LOX
• UDI-Device Identifier: 08717648153983
• UDI-Public: (01)08717648153983(17)180831(10)50930G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1012405-15
• Device Lot Number: 50930G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1