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

Catalog Number	ATG80124
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
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 device was returned for evaluation.A visual inspection found the proximal end of the balloon to have detached from the outer catheter.Additionally, a complete catheter detachment was identified to the inner guidewire lumen, at an unknown location inside the outer catheter.Therefore, the investigation is confirmed for both balloon and catheter detachment.Based on the stretched inner guidewire lumen, prolapsed balloon material, and detached components, the investigation is confirmed for retraction issues.Additionally, the investigation is confirmed for a dislodged proximal marker band.The investigation is inconclusive for the reported pinhole rupture, as full functional testing could not be conducted due to the detached components.It is possible that a pinhole rupture could have contributed to resistance retracting the device through an introducer sheath.Resistance of the balloon in the sheath, likely resulted in the identified detachments, as signs of applied excessive force were identified on the returned device.However, the definitive root cause for the reported pinhole rupture or retraction issue could not be determined 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 angioplasty procedure of a right central occlusion, an alleged pinhole rupture occurred and was subsequently difficult to retract from the sheath.It was further reported that upon attempts to retract the balloon through the sheath, the catheter shaft allegedly detached.The balloon catheter and sheath were removed together as one unit.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6989160
• Report Number: 2020394-2017-01469
• Device Sequence Number: 16369498
• Product Code: LIT
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/30/2017

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 Expiration Date: 03/03/2020
• Device Catalogue Number: ATG80124
• Device Lot Number: 93PB0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1