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

Catalog Number	1012446-15
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
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.Product performance engineering reviewed the incident information, however, the product was not returned to abbott vascular for analysis.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that when the balloon catheter was advanced toward the lesion the device met resistance with the moderately calcified anatomy causing the reported resistance during advancement.Additional manipulation and/or inadvertent mishandling of the device during advancement against resistance likely compromised or damaged the balloon resulting in the reported balloon rupture during the first inflation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a concentric lesion in the distal right coronary artery with no tortuosity and moderate calcification.Following pre-dilation with a non-abbott balloon dilatation catheter (bdc), a 2.25 x 15 mm nc trek rx bdc was advanced to the lesion, with resistance from the anatomy, for additional dilatation.The nc trek rx balloon ruptured on the first inflation at 6 atmospheres for 10 seconds.The bdc was simply replaced with an additional unspecified bdc to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in 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: 8042665
• Report Number: 2024168-2018-08506
• Device Sequence Number: 13768748
• Product Code: LOX
• UDI-Device Identifier: 08717648151705
• UDI-Public: 08717648151705
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 12/31/2020
• Device Catalogue Number: 1012446-15
• Device Lot Number: 80119G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1