MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER

Catalog Number	C12009
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pressurewire x cabled outside package and inner package were torn.Sterility was compromised, therefore the device was not used.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported packaging damage was unable to be confirmed as there was no hole/damage visible to the returned packaging pouch as described.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided and analysis of the returned device, the cause for the packaging damage was related to operational context.Based on the presence of a complete perimeter on the tyvek seal and the lack of any damage to the pouch, it is likely that the opening of the pouch was caused incidentally by the user during storage (most likely premature unpacking).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Common Device Name: CATHETER TIP PRESSURE TRANSDUCER
• 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: 19242053
• Report Number: 2024168-2024-05462
• Device Sequence Number: 7430718
• Product Code: DXO
• UDI-Device Identifier: 05415067025739
• UDI-Public: (01)05415067025739(17)250331(10)30427G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: C12009
• Device Lot Number: 30427G1
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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