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

Model Number	B1120-060
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat a lesion in the iliac artery.The 12mm x 60mm armada 35 balloon dilatation catheter (bdc), was used without issue; however, during removal, resistance was felt with the 6f non-abbott introducer sheath.The balloon shredded inside of the introducer sheath and the tip of the catheter broke but did not separate in two pieces.The procedure was complete at this time, the bdc and introducer sheath were removed as a single unit.There were no adverse patient effects and there was no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot revealed no other complaints.Based on the information provided, a definitive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Device not available for evaluation.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9885018
• Report Number: 2024168-2020-02972
• Device Sequence Number: 19520511
• Product Code: LIT
• UDI-Device Identifier: 08717648154997
• UDI-Public: 08717648154997
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 01/31/2021
• Device Model Number: B1120-060
• Device Catalogue Number: B1120-060
• Device Lot Number: 70821G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F PRELUDE INTRODUCER SHEATH