MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B1070-080
Medical Device Problem Codes	Difficult to Remove (1528); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 7.0x80mm armada 35 balloon dilatation catheter (bdc) was opened and noted to have a hair inside the package.The device was not used.Another armada 35 was used to successfully complete the procedure.There were no adverse patient effects reported and no clinically significant delay in the procedure.Per device analysis the protective sheath was frozen on the balloon.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
Visual inspections was performed on the returned device.The reported issue was not confirmed.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint or noted frozen sheath on the balloon.Return analysis was unable to confirm a hair on the device as reported which indicates that contaminant was not embedded on the device.In this case, it is possible that the device was either packaged with the reported hair or it became contaminated at the account; however, a conclusive cause cannot be determined.Furthermore, the returned device noted the protective sheath was returned frozen on the device.The account was unable to state why the sheath was removed from the device if it was not going to be used.In this case, it is possible that the sheath was removed during unpackaging of the device and once the account realized the device wasn¿t going to be used the sheath was put back on the balloon to return to abbott vascular; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6 medical device problem code 1528 'difficult to remove' was removed.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL 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: 15670329
• Report Number: 2024168-2022-11032
• Device Sequence Number: 6497700
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/08/2022

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: 11/30/2023
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 00622G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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