MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident information was reviewed; 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.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.In this case, 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.The investigation was unable to determine a conclusive cause for the reported balloon rupture.In this case, it is possible that during advancement the balloon became compromised and/or damaged against the anatomy or other devices used in the procedure; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.The two additional armada devices referenced filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery.No calcification or tortuosity was noted.Atherectomy was performed and then 3 armada 18 percutaneous transluminal angioplasty (pta) catheters were used.Two armada 18 6.0x120 mm pta catheters ruptured on the first inflation to 7 or 8 atmospheres (atm), and an armada 18 6.0x80 mm pta catheter also ruptured on the first inflation to 7 or 8 atm.There was no noted resistance during advancement or removal.A non-abbott balloon was used last and also ruptured.A supera self-expanding stent was then successfully deployed 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 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11735379
• Report Number: 2024168-2021-03591
• Device Sequence Number: 14364203
• Product Code: LIT
• UDI-Device Identifier: 08717648208416
• UDI-Public: 08717648208416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 04/27/2021

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: 01/31/2022
• Device Model Number: 1013470-080
• Device Catalogue Number: 1013470-080
• Device Lot Number: 8081741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 80