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

Catalog Number	1012447-08
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
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.Concomitant medical products: guide wire: sion; guide cath: launcher 6f jl4; stent: onyx 2.5 x 26.The incident information was reviewed; however, the product was not returned 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.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% stenosed, heavily calcified lesion in the distal left circumflex coronary artery.Pre-dilatation was performed and a non-abbott stent was placed in the target lesion.A 2.50x8mm nc trek rx balloon dilatation catheter (bdc) was advanced without resistance to the lesion for post-dilatation.The balloon ruptured during the first inflation at 14 atmospheres for 10 seconds.The bdc was removed without resistance and a new same size non-abbott bdc was used to complete the procedure.There was no reported adverse patient effect and no reported 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: 7846819
• Report Number: 2024168-2018-06884
• Device Sequence Number: 1536707
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• 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): 09/05/2018

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: 08/31/2020
• Device Catalogue Number: 1012447-08
• Device Lot Number: 70921G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1