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

Model Number	B2070-040
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device code (b)(4).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 tortuous, mildly calcified de novo subclavian vein that was 80% stenosed.A 7x40mm armada 35 balloon was inflated once and ruptured transversely at 15 atmospheres.Another same size armada 35 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.
Additional Manufacturer Narrative
B1, h1: type of reportable event changed from malfunction to serious injury health effect impact code 2199 was removed.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified de novo subclavian vein that was 80% stenosed.A 7x40mm armada 35 balloon was inflated once and ruptured transversely at 15 atmospheres.Another same size armada 35 was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, device analysis noted the balloon and inner member were separated distal to the balloon proximal seal and the separated portions was not returned.The account confirmed that the separation occurred during the procedure and that the separated device portions were removed via snare.Angiography confirmed that nothing remained in the patient's anatomy.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified de novo subclavian vein that was 80% stenosed.A 7x40mm armada 35 balloon was inflated once and ruptured transversely at 15 atmospheres.Another same size armada 35 was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device analysis noted the balloon and inner member were separated distal to the balloon proximal seal and the separated portions were not returned.The account confirmed that the separation occurred during the procedure and that the separated device portions were removed via snare.Angiography confirmed that nothing remained in the patient¿s anatomy.Additional information was received by the account stating: the armada balloon was used to dilate the stenosed synthetic arteriovenous fistula graft instead of the central subclavian vein as initially reported.After the balloon ruptured at 15 atmospheres, the physician found no residual device in the patient's body via angiography.However, it was later confirmed that the armada 35 balloon had separated and the separated portions were never snared as previously reported and remain in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
Visual and scanning electron microscopy (sem) inspection/analysis were performed on the returned device.The reported balloon rupture and separations were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The sem report determined the balloon exhibited a longitudinal rupture intersected by radial tearing.The origin area was not identified on the proximal half of the balloon separation and may possibly be along the longitudinal rupture on the distal half of the separation.The inner member exhibited a jagged edge, necking and bunching.The edge of the rupture exhibited tearing.The investigation determined the reported complaint and foreign body in patient appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Codes 4641, 4582, 1494 were removed.

• 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: 12160452
• Report Number: 2024168-2021-06003
• Device Sequence Number: 4615872
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• 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,Followup
• Report Date (Section B): 09/16/2021

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: 02/29/2024
• Device Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 00910G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 09/02/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention