MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2060-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.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 reported from this lot.A photo was returned for review.Based on the photo provided the balloon appears to have a radial separation on the working length.A longitudinal rupture is also visible on the working length extending distally towards the tip.A conclusive cause for the reported patient effects of pain and delirium, and the relationship to the product, if any, cannot be determined.The reported patient effect of pain is listed in the instructions for use percutaneous transluminal angioplasty catheter, armada 35/armada 35 long length as a known patient effect of the procedure.The investigation was unable to determine a conclusive cause for the reported balloon and tip separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a chronic total occlusion, heavily calcified, mid superficial femoral artery.A 6.0x100mm armada 35 balloon dilation catheter (bdc) was inflated to nominal pressure one time without issue.There was no resistance felt during withdrawal.The patient was discharged; however, a few weeks after the procedure, the patient felt pain in the leg and was re-hospitalized for treatment.The patient's leg was surgically opened and it was confirmed that the tip and balloon of the armada 35 were still in the vessel.Both were successfully removed.After the incident, the patient felt delirium and was hospitalized in a nursing hospital for rest as treatment.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8689431
• Report Number: 2024168-2019-04613
• Device Sequence Number: 3019644
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: 07/31/2021
• Device Catalogue Number: B2060-100
• Device Lot Number: 80217G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR