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

Model Number	1012452-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the proximal left anterior descending coronary artery that was non-calcified and non-tortuous.The nc trek 3.75 x 20 mm balloon dilatation catheter was being used for post dilatation, but completely failed to inflate.The device was removed from the anatomy and another same size nc trek was used to complete the procedure.The device was prepped according to the instructions for use and there was no resistance during removal of the protective sheath.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) was unable to confirm the reported inflation issue, but did identify a stretched shaft outer member.The balloon was pressurized to rated burst pressure without difficulty.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.A review of the complaint handling database found similar incidents from this lot.Av conducted root cause analysis and determined the most probable cause is variability in the manufacturing process.No action is needed at this time as preventative actions were previously implemented and the complaint rate for this issue continues to decline.Av will continue to trend the performance of these devices.

• 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: 6644633
• Report Number: 2024168-2017-05098
• Device Sequence Number: 13723726
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: (01)08717648152047(17)200131(10)70206G1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 08/15/2017

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: 01/31/2020
• Device Model Number: 1012452-20
• Device Catalogue Number: 1012452-20
• Device Lot Number: 70206G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR