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

Catalog Number	1012451-25
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 other similar incidents from this lot.It should be noted the instructions for use, states: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
The procedure was to treat a lesion located in the distal right coronary artery (rca) with heavy calcification.Resistance was not felt during advancement of the 3.5 x 25 mm nc trek balloon dilatation catheter (bdc) to the lesion and it crossed successfully; however, during the second inflation at over 12 atmospheres, the balloon ruptured.When the bdc was being retracted from the lesion, resistance was felt due to the calcification and the balloon separated and remained in the rca.A 3.5 x 38 mm xience stent delivery system (sds) was used to stent the balloon to the vessel wall.It was further reported that the balloon was not submerged in saline prior to use.A new bdc was used to complete the procedure.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: 6455409
• Report Number: 2024168-2017-02775
• Device Sequence Number: 10903465
• Product Code: LOX
• UDI-Device Identifier: 08717648152009
• UDI-Public: (01)08717648152009(17)191231(10)70109G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1012451-25
• Device Lot Number: 70109G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention