MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2040-120
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
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.The device was not returned for analysis.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 of the reported lot revealed no indication of a lot specific product issue.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that after deflation, the balloon was caught with the occluded previously implanted stent, resulting in difficulty removing and separation of the balloon; however, this could not be confirmed.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 an occluded, previously stented lesion in the superficial femoral artery.A 4.0 x 120 mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced with no reported resistance and the balloon was inflated once to an unknown pressure.There were no reported problems with deflation.Resistance of an unknown origin was met when attempting to remove the pta balloon catheter.The pta balloon catheter was removed as a single unit; however, outside of the anatomy, it was noted that the balloon had separated from the catheter and was found to be in multiple pieces.A buddy catheter was used to retrieve all the separated pieces of the balloon from the patient's anatomy and contrast was used to confirm the buddy catheter was successful.No further intervention was performed.There was no reported adverse patient sequela and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
(b)(4).Correction: the date received by mfr was filed incorrectly on the initial medwatch report as 10/04/2018, but should have been 10/02/2018.
Event or Problem Description
Subsequent to the initial/ final filed report the following information was received: the balloon was inflated once to 8 atmospheres for 3 minutes.No additional information was provided.

• Brand Name: ARMADA 14 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: 7944345
• Report Number: 2024168-2018-07752
• Device Sequence Number: 857233
• Product Code: LIT
• UDI-Device Identifier: 08717648156168
• UDI-Public: 08717648156168
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 05/31/2021
• Device Catalogue Number: A2040-120
• Device Lot Number: 7121241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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: GUIDE WIRE: COMMAND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 73