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

Model Number	B2070-120
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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 other similar incidents and/or complaints reported from this lot.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the heavily calcified anatomy, the balloon outer surface became damaged resulting in the reported balloon rupture during the inflation at 10 atmospheres.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified superficial femoral artery (sfa).The armada percutaneous transluminal angioplasty (pta) catheter was inflated once to 10 atm and ruptured.No resistance was noted during advancement.Another armada pta catheter was used to complete the procedure.There were no adverse patient effects and there was 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: 10994297
• Report Number: 2024168-2020-10415
• Device Sequence Number: 14322255
• Product Code: LIT
• UDI-Device Identifier: 08717648155390
• UDI-Public: 08717648155390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/11/2020

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: 07/31/2023
• Device Model Number: B2070-120
• Device Catalogue Number: B2070-120
• Device Lot Number: 00211G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 132