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

Catalog Number	1012448-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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.The product was not returned to abbott vascular for analysis.The investigation was unable to determine a conclusive cause for the reported balloon rupture.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.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, moderately calcified, de novo lesion in the mid left anterior descending coronary artery.A 2.75x20mm nc trek rx balloon dilatation catheter (bdc) was advanced to the lesion, without resistance, to perform dilatation; however, the balloon ruptured during the first inflation at 8 atmospheres.The bdc was removed without resistance and replaced with a non-abbott bdc to perform dilatation.A non-abbott stent was deployed in the target lesion to complete the procedure.There was no 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: 8071847
• Report Number: 2024168-2018-08810
• Device Sequence Number: 1582393
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: 08717648151835
• 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): 11/14/2018

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: 12/31/2019
• Device Catalogue Number: 1012448-20
• Device Lot Number: 70111G2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1