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

Catalog Number	1012447-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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.It was reported that the balloon was not soaked prior to use.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.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, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, 70% stenosed, de novo lesion in the moderately tortuous left anterior descending (lad) coronary artery below a bifurcation.After implanting a non-abbott stent in the lad, a non-abbott balloon was advanced to the diagonal coronary branch.A 2.5x8mm nc trek rx balloon dilatation catheter (bdc) was unpackaged without difficulty, the bdc was not soaked during prep, and air aspiration was performed prior to use.The nc trek rx bdc was then advanced to the lad stent without resistance, for dilatation via kissing balloon technique.While the nc trek rx balloon was able to be inflated twice to 10 atmospheres (atm) without difficulty and deflated without difficulty, the balloon ruptured at 10 atm during the 3rd inflation (noted when gauge pressure was lost), thus, making it impossible to inflate the balloon any longer.Another non-abbott balloon was used to complete dilatation in the lad stent.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: NC 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: 6575537
• Report Number: 2024168-2017-04249
• Device Sequence Number: 226077
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: (01)08717648151743(17)190831(10)60912G1
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K110134
• 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): 05/18/2017

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: 08/31/2019
• Device Catalogue Number: 1012447-08
• Device Lot Number: 60912G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1