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

Model Number	B1140-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: estimated date.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 one other complaint.However, this complaint is related to the same event with the reported difficulties.Based on the information provided, a definitive cause for the reported material rupture could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada device is being filed under a separate medwatch report #.
Event or Problem Description
It was reported that the procedure was performed to treat an unspecified lesion.The 14x80mm armada 35 balloon ruptured at an unspecified pressure while attempting to post dilate a non-abbott stent.The same occurred with a new 14x80mm armada 35 balloon.In the physician¿s opinion, the balloons ruptured due to the jaggedness of the non-abbott stent.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10314207
• Report Number: 2024168-2020-06146
• Device Sequence Number: 812306
• Product Code: LIT
• UDI-Device Identifier: 08717648155048
• UDI-Public: 08717648155048
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 07/23/2020

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: 06/30/2023
• Device Model Number: B1140-080
• Device Catalogue Number: B1140-080
• Device Lot Number: 00106G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1