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

Model Number	B1100-060
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is being filed under a separate medwatch report#.
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt procedure, a 10.0x100mm absolute pro stent was deployed on a bend.After dilatation with a 10.0x60mm armada 35 balloon dilatation catheter, it was observed that more than one stent strut fractured in the middle of the stent but the stent remained as one.The fractured stent remains in the patient.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no indication of a lot specific product quality issue.The investigation determined the reported event was due to case circumstances.The damage to the stent was likely the result of dilating with the armada 35 balloon catheter and the stent fractured in the middle segment bend location as reported.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 10838183
• Report Number: 2024168-2020-09515
• Device Sequence Number: 4177630
• Product Code: LIT
• UDI-Device Identifier: 08717648154959
• UDI-Public: 08717648154959
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 03/31/2022
• Device Model Number: B1100-060
• Device Catalogue Number: B1100-060
• Device Lot Number: 81004G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: ABSOLUTE PRO
• Patient Age: 85 YR
• Patient Weight: 65