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

Catalog Number	B2070-200
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
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.The lot history record could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the balloon rupture occurred due to interaction with the anatomy or associated devices during use causing damage to the outer surface of the balloon material resulting in the rupture under pressure.Additionally, the separation likely occurred during removal as the ruptured balloon material caught in the introducer sheath during removal.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 a 7 x 200 mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with no resistance; however, the balloon ruptured and separated on the first inflation.The pressure that the balloon of the pta balloon catheter ruptured at is not known at the inflation was performed with a 3cc syringe and not a pressure monitored device.A snare was used to successfully retrieve all the separated pieces of the balloon from the patient anatomy.The patient was reported to be doing well post procedure and there was no clinically significant delay.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: 8562667
• Report Number: 2024168-2019-03394
• Device Sequence Number: 1587115
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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
• Report Date (Section B): 04/29/2019

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 Catalogue Number: B2070-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: Required Intervention