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

Model Number	B1060-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
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 lesion in the common femoral artery with moderate to severe stenosis.A 6mmx100mm armada 35 balloon dilatation catheter (bdc) was taken to the lesion and ruptured circumferentially on the 2nd inflation at 12 atmospheres (atm).During removal, the balloon bunched and the bdc could not be removed from the distal end of the sheath.A cut down and arteriotomy was performed to remove the ruptured balloon.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and scanning electron microscopy (sem) analysis were performed on the returned bdc and the reported balloon rupture was confirmed.The reported difficulty to remove was unable to be confirmed due to the returned condition of the device.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.The device was prepped prior to use and inflated once prior to the reported balloon rupture with no issue noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, returned analysis and sem analysis, it is likely that during the second inflation, the balloon surface became damaged and/or compromised against the anatomy resulting in the reported balloon rupture during the second inflation.Due to the balloon rupture, the balloon did not properly refold causing resistance with the sheath and the reported bunching on the balloon resulting in the difficulty to remove.It is likely that manipulation against resistance with the sheath ultimately resulted in the noted separations and subsequent damages to the bdc.The reported treatments appear to be related to the operational context of the procedure as a surgical cut down and arteriotomy were performed in order to remove the ruptured balloon.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

• 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: 10577745
• Report Number: 2024168-2020-07973
• Device Sequence Number: 16927615
• Product Code: LIT
• UDI-Device Identifier: 08717648154720
• UDI-Public: 08717648154720
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 01/31/2023
• Device Model Number: B1060-100
• Device Catalogue Number: B1060-100
• Device Lot Number: 90830G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR SHEATH.; 9 FR SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR