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

Catalog Number	1012452-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
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.The device was not returned for evaluation.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.It should be noted coronary dilatation catheters, nc trek rx, instruction for use, states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.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.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 threat a de novo concentric lesion located in the mid right coronary artery (rca) with moderate tortuosity and heavy calcification that was 90% stenosed.Resistance was not felt during the advancement of the 3.75mm x 15 mm nc trek rx balloon dilatation catheter (bdc) for pre-dilatation and it crossed the lesion successfully; however, during the first inflation, the balloon ruptured at 7 atmospheres.It was stated that air aspiration (device prep) was performed inside the anatomy.A new 3.5 x 15 mm nc trek bdc was used for pre-dilatation.The procedure was completed after a non-abbott sent was implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.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: 6526677
• Report Number: 2024168-2017-03650
• Device Sequence Number: 738961
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: (01)08717648152030(17)180531(10)50609G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/27/2017

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: 05/31/2018
• Device Catalogue Number: 1012452-15
• Device Lot Number: 50609G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SIONGUIDE CATH: HYPERION