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

Model Number	B2060-020
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that during advancement the balloon became compromised and/or damaged against the heavily calcified anatomy and/or other devices used in the procedure resulting in the reported balloon rupture; however, this could not be confirmed.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 performed to treat a heavily calcified, heavily tortuous de novo left superficial femoral artery that was 99% stenosed.The lesion was approached via the right common femoral artery.The 6x20mm armada 35 balloon ruptured on the first inflation at nominal pressure.The balloon was removed and replaced with a same size non-abbott balloon and a non-abbott stent to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10959105
• Report Number: 2024168-2020-10202
• Device Sequence Number: 558629
• Product Code: LIT
• UDI-Device Identifier: 08717648155253
• UDI-Public: 08717648155253
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/07/2020

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: 07/31/2021
• Device Model Number: B2060-020
• Device Catalogue Number: B2060-020
• Device Lot Number: 80214G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1