MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER

Catalog Number	1012451-20
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified left anterior descending artery.During removal of a 3.50x20mm nc trek balloon dilatation catheter after inflation, resistance was met with the anatomy and the catheter shaft became stretched.A 1.5mm unspecified balloon was used to inflate the stuck portion and everything was able to be removed successfully without issue.There were no adverse patient effects or clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual inspection was performed on the returned device.The reported separation and stretching were confirmed.The reported entrapped device could not be replicated in a testing environment as it was based on operational circumstances.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 other similar incidents/complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Mfr site - contact office first and last name was updated from (b)(6) to (b)(6).
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified left anterior descending artery.During removal of a3.50x20mm nc trek balloon dilatation catheter after inflation, resistance was met with the anatomy and the catheter shaft became stretched.A 1.5mm unspecified balloon was used to inflate the stuck portion and everything was able to be removed successfully without issue.There were no adverse patient effects or clinically significant delay reported.No additional information was provided.Additional information received (b)(6) 2019: the proximal shaft became separated during the procedure during removal.No additional information was provided.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8865780
• Report Number: 2024168-2019-10600
• Device Sequence Number: 2078828
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 1012451-20
• Device Lot Number: 90424G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention