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

Catalog Number	1012453-20
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual, dimensional and functional inspection were performed on the returned device.The reported deflation issue was unable to be confirmed due to the leak on the outer member.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It was determined that the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.User facility (voluntary) medwatch report number mw5079570.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and mildly calcified left anterior descending artery.An unspecified stent was implanted and post-dilatation was performed with a 4.0 x 20 mm nc trek balloon dilatation catheter (bdc).The device did not meet any resistance during advancement, and the balloon was inflated at 14 atmospheres (atms) and then at 12 atms.However, the balloon was unable to be deflated; therefore, the device was gently pulled out of the anatomy with the balloon fully inflated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Additionally, a voluntary medwatch report was received which states: post stent ptca lad, balloon would not deflate in artery.Had to be pulled out inflated.No harm but potential to delay in procedure.Device was prepped prior to use.No resistance during advancement.Device was inflated twice in the procedure, first to 14 then 12.Balloon would not deflate until removed from the artery.Mild calcium and tortuosity.

• 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: 7889382
• Report Number: 2024168-2018-07266
• Device Sequence Number: 16621499
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 04/30/2021
• Device Catalogue Number: 1012453-20
• Device Lot Number: 80515G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR