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

Model Number	B1060-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.It is likely that the balloon rupture was the result of inflating the balloon over the rbp.The instructions for use, states: inflation in excess of the rated burst pressure may cause the balloon to rupture.The lot history record (lhr) for this product 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 determined that the reported difficulties appear to be user related.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada devices are filed under separate medwatch reports.
Event or Problem Description
It was reported that procedure was to treat a right arm fistula with 80% stenosis.A 6mm x 20mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion.During the first inflation, to 24 atmospheres (atm) the balloon ruptured (rbp).The armada bdc was replaced with another same size armada bdc and during the first inflation to 24 atm the balloon ruptured.A 7mm x 40mm armada bdc was advanced to the target lesion.During the third inflation, to 24 atm the balloon ruptured.The 7mm x 40mm armada bdc was difficult to remove from the sheath.The devices were removed together as a single unit.Upon removal of the device, it was noted that a portion of the balloon along with part of the inner member with the balloon marker remained in the patient anatomy.An attempt to snare the separated portion of the balloon was unsuccessful, a cut down was performed to remove the separated balloon.No additional treatment was required; the procedure was complete at this time.The patient is stable.There was no adverse patient sequela and no clinically significant delay in the procedure.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: 6684841
• Report Number: 2024168-2017-05623
• Device Sequence Number: 72492
• Product Code: LIT
• UDI-Device Identifier: 08717648154683
• UDI-Public: (01)08717648154683
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B1060-020
• Device Catalogue Number: B1060-020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 84