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

Model Number	B1040-020
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
During preparation a 4.0x20mm armada 35 pta catheter was attempted to be inflated; however failed.The balloon was noted to have a tear.There was no patient involvement and no clinically significant delay.Another unspecified device was used to successfully complete the procedure.No additional information was provided.
Event or Problem Description
It was reported that during preparation a 4.0x20mm armada 35 pta catheter was attempted to be inflated; however failed.The balloon was noted to have a tear.There was no patient involvement and no clinically significant delay.Another unspecified device was used to successfully complete the procedure.Correction: the reported leak was noted during preparation when performing air aspiration.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported leak was unable to be confirmed on the returned device as the balloon was able to inflate and hold pressure.Additionally, it was not guaranteed that the correct device had returned.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.Possible factors that may contribute to balloon damage or balloon leaks may include, but are not limited to, manufacturing, damage to the balloon during unpacking, incorrect prep, damaged balloon during prep or balloon inflation prior to soaking.The investigation was unable to determine a conclusive cause for the reported balloon leak during prep.It was noted that the balloon on the returned device was flat.It is possible that a balloon could have interacted with the stent and/or other devices during deflation causing the flat deflation.A flat balloon is not uncommon especially when deflated outside of the body.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6- medical device problem code 1546 was removed and replaced with code 1354.B5: additional information was added.

• 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: 10935375
• Report Number: 2024168-2020-10095
• Device Sequence Number: 10980655
• Product Code: LIT
• UDI-Device Identifier: 08717648154508
• UDI-Public: 08717648154508
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/17/2021

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: 05/31/2023
• Device Model Number: B1040-020
• Device Catalogue Number: B1040-020
• Device Lot Number: 91216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1