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

Catalog Number	1012451-25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: runthrough, guide cath: medtronic launcher 6fr jr4.(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the device from the guiding catheter could not be confirmed.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 incidents from this lot.It should be noted that the coronary dilatation catheters nc trek rx, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek is 18 atms.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the reported difficulty removing the device appears to be related to operational context.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 the procedure was to treat a lesion in the right coronary artery (rca).The 3.5x23mm nc trek balloon catheter was advanced to the lesion and inflated twice, once to 18 atmospheres (atm) and once to 20 atm.The balloon was completely deflated prior to withdrawal.Resistance was met at the tip of the 6fr guiding catheter and the nc trek balloon could not be completely removed.The balloon catheter, guiding catheter, and guide wire were removed as a system.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7627428
• Report Number: 2024168-2018-04808
• Device Sequence Number: 1818295
• Product Code: LOX
• UDI-Device Identifier: 08717648152009
• UDI-Public: 08717648152009
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/21/2018

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: 05/31/2020
• Device Catalogue Number: 1012451-25
• Device Lot Number: 70629G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 110