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

Model Number	B1050-020
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: estimated date.(b)(4).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 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, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.It should be noted that the pta, armada 35 / armada 35 ll, global, ce, (b)(4) instructions for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.In this case, based on the reported information, the inflation above rated burst pressure appears to have been unintentional and it is undetermined if the inflation above rbp caused or contributed to the reported balloon rupture.The investigation was unable to determine a conclusive cause for the reported inflation issue and balloon rupture.Based on the reported information, it is possible that the anatomical conditions did not allow the contrast medium to dilate the balloon.Further attempts to inflate the balloon ultimately caused the contrast to rush through the balloon expanding the balloon above rated burst pressure resulting in the 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 non-calcified, non-tortuous fistula with moderate stenosis.The 5.0x20mm armada 35 balloon would not inflate, then the balloon suddenly and rapidly inflated past burst pressure and burst at an unknown pressure.A new unspecified balloon was used 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: 11879144
• Report Number: 2024168-2021-04389
• Device Sequence Number: 1099412
• Product Code: LIT
• UDI-Device Identifier: 08717648154591
• UDI-Public: 08717648154591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 06/30/2024
• Device Model Number: B1050-020
• Device Catalogue Number: B1050-020
• Device Lot Number: 10118G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1