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

Model Number	B1060-080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
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 that the shaft of the 6x80mm armada 35 balloon catheter was leaking and the catheter did not hold pressure.The procedure was successfully completed with a new unspecified armada 35 balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspections were performed on the returned device and the reported shaft leak was unable to be confirmed, as the device was pressurized to rated burst pressure and held pressure without any leaks noted.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 other similar incidents and/or complaints reported from this lot.Factors that may contribute to leaks include, but are not limited to: manufacturing, damage to the sidearm, damage to the inflation lumen, damage to the outer shaft/outer member or a loose connection.The investigation was unable to determine a conclusive cause to the reported shaft leak.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: 10071961
• Report Number: 2024168-2020-04389
• Device Sequence Number: 13644702
• Product Code: LIT
• UDI-Device Identifier: 08717648154713
• UDI-Public: 08717648154713
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 04/30/2023
• Device Model Number: B1060-080
• Device Catalogue Number: B1060-080
• Device Lot Number: 91119G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1