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

Model Number	B1040-040
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous atrioventricular (av) fistula.The 4.00x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter failed to inflate and was losing pressure when attempting to inflate.After it was removed, it was found that the balloon leaked air but the source could not be found.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.Another armada 35 was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported rupture and inflation issue were unable to be confirmed as the balloon inflated and held pressure.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.Factors that may contribute to inflating issues of the device may include, but are not limited to, damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast dilution, inadequate/loose connection to the inflation device, and/or accessory device support.The investigation was unable to determine a conclusive cause for the reported inflation issue and balloon rupture.The noted wrinkling of the balloon and inner member kinks likely occurred during reloading of the protective sheath for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11376330
• Report Number: 2024168-2021-01458
• Device Sequence Number: 4076660
• Product Code: LIT
• UDI-Device Identifier: 08717648154515
• UDI-Public: 08717648154515
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 11/30/2023
• Device Model Number: B1040-040
• Device Catalogue Number: B1040-040
• Device Lot Number: 00616G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1