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

Model Number	B1070-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 no other complaints reported from this lot.Based on the information provided, the reported balloon rupture, difficulty removing, material separation and surgical procedure was likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the previously placed stent or anatomy which was described as calcified.Additionally, the difficulty removing, and separation likely occurred due to the ruptured balloon material catching on the introducer sheath during removal resulting in surgery to retrieve the separated portion of the balloon.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the right common and superficial femoral arteries with calcification.During the procedure, the 7.0x80 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was being used to post-dilate a stent.The balloon was inflated to 8 atmospheres and when it was attempted to increase the pressure, the balloon ruptured.Resistance was noted during removal with the sheath and it was tried to push the balloon and withdraw it together with the sheath.When pulled, a portion separated and the patient had to be sent to surgery to retrieve the separated portion of the balloon.The patient recovered well.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: 11838511
• Report Number: 2024168-2021-04141
• Device Sequence Number: 4545437
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 01016G2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention