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

Catalog Number	1012278-12
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional trek rx device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that during preparation, the 4.0x12 mm trek balloon dilatation catheter (bdc) was removed from the dispenser hoop and it was noted that the hypotube had been punctured by the stylet which was out of place in the packaging.Another 4.0x12 mm trek bdc was removed from the dispenser hoop when the same issue was noted.The outer packaging of both devices was not damaged.The devices were not used and there was no patient involvement.A new, same size trek bdc was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection were performed on the returned device.The reported material split, cut or torn was confirmed as a tear on the guide wire exit notch.The reported device misassembled during manufacturing could not be confirmed due to the returned condition.A review of the production records was performed and revealed no related complaint assessment or manufacturing nonconformities.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that the hypotube had been punctured by the stylet.Analysis of the returned device noted the tear to be on the guide wire exit notched.This type of damage is consistent with interaction between the stylet and guide wire exit notch.The noted damage can occur if the wire is inadvertently pulled against the balloon catheter.It is possible that inadvertent mishandling during stylet removal contributed to the reported damage; however this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that during preparation, the 4.0x12 mm trek balloon dilatation catheter (bdc) was removed from the dispenser hoop and it was noted that the hypotube had been punctured by the stylet which was out of place in the packaging.Another 4.0x12 mm trek bdc was removed from the dispenser hoop when the same issue was noted.The outer packaging of both devices was not damaged.The devices were not used and there was no patient involvement.A new, same size trek bdc was used to complete the procedure.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported that the devices were prepped before the stylet was noted to be punctured through the hypotube and the protective sheath was present and intact.No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19097369
• Report Number: 2024168-2024-04619
• Device Sequence Number: 7343954
• Product Code: LOX
• UDI-Device Identifier: 08717648138706
• UDI-Public: (01)08717648138706(17)250331(10)20429G1
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 03/31/2025
• Device Catalogue Number: 1012278-12
• Device Lot Number: 20429G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown