MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number	ATG120184
Medical Device Problem Codes	Retraction Problem (1536); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during an upper arm fistula the pta balloon material allegedly began to unravel at the distal end of the balloon when the inflation attempt was at approximately 6atm.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the original device was returned with the user's 9 fr introducer sheath.A visual inspection of the original device found the balloon to be completely detached from the device and returned lodged in the sheath.Additionally, the balloon material was prolapsing from the distal end of the sheath, and the sheath was noted to be flared and buckled.Therefore, the investigation is confirmed for a complete balloon detachment, as well as for sheath-related retraction issues.The proximal marker band was noted to be dislodged, so the investigation is also confirmed for dislodgment.The investigation is inconclusive for the reported material unraveling on the balloon as the balloon was fully detached and lodged within the returned sheath.Based on the condition of the returned sample, it is likely that resistance was encountered by the user leading to excessive force being applied to the device as it was being withdrawn through the sheath.This excessive force led to the balloon being detached within the sheath, and the marker band being dislodged.However, the definitive root cause for the identified retraction issues could not be identified based on the available information.Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Use of the atlas gold pta dilation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over-the-wire through the introducer sheath.Use of a gentle clockwise motion may be used to help facilitate catheter removal through the introducer sheath.(b)(4).
Event or Problem Description
It was reported that during an upper arm fistula the pta balloon material allegedly began to unravel at the distal end of the balloon when the inflation attempt was at approximately 6 atm.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7113099
• Report Number: 2020394-2017-01740
• Device Sequence Number: 13771177
• Product Code: LIT
• UDI-Device Identifier: 00801741060885
• UDI-Public: (01)00801741060885
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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 Expiration Date: 10/30/2020
• Device Catalogue Number: ATG120184
• Device Lot Number: 93XB0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 91