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

Model Number	B2040-100
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 4x100mm armada 35 percutaneous transluminal angioplasty (pta) was received by the customer with blood on the outside packaging.The device was not used and there was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
The device was returned and the reported complaint was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed and analysis of the returned device, the reported contamination appears to be due to case circumstances.The noted contamination (blood) was likely due to handling of the packaging at the account.The noted crushed portion on the bottom right-hand corner of the chipboard box may have occurred during transport for return of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 OTW
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9916678
• Report Number: 2024168-2020-03272
• Device Sequence Number: 654578
• Product Code: LIT
• UDI-Device Identifier: 08717648155116
• UDI-Public: 08717648155116
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 10/31/2021
• Device Model Number: B2040-100
• Device Catalogue Number: B2040-100
• Device Lot Number: 80511G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1