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	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
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 following an angioplasty procedure in a subclavian central stenosis, the pta balloon catheter allegedly could not be retracted through the 7fr sheath.The balloon and sheath were removed as a single unit and another balloon 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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 12mm x 4cm balloon.The device was returned with the balloon stuck in a introducer sheath.The distal end of the balloon was found to be protruding from the distal end of the sheath, and was prolapsed; the distal end of the sheath was examined under microscopic magnification (10x) and was found to be flared, indicating retraction issues.The device was returned with a complete circumferential break noted at the proximal glue joint; the inner lumen was intact but kinked in multiple locations.Kinks were noted throughout the catheter's length, likely a result of the retraction issues.No kinks were reported by the user.The proximal cone of the balloon was detached and was returned within the sheath; fibers were still visibly bonded to the proximal balloon weld joint.While handling the device the remainder of the catheter pulled out of the introducer sheath with the balloon remaining within the sheath.Traces of the balloon and fibers were noted to still be welded to the distal end of the catheter.Functional/performance evaluation: no further functional testing could be performed due to the poor sample condition (i.E.Detached balloon).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned with the balloon lodged in an introducer sheath.The distal end of the balloon was found to be prolapsed and the introducer sheath was found flared at the distal tip, confirming the investigation for sheath-related retraction issues.Additionally, the investigation is confirmed for a completed balloon detachment, as the balloon was returned detached from both the proximal and distal balloon weld locations.Additionally, the investigation is confirmed for a circumferential break of the outer catheter at the proximal glue joint.It is likely that excessive force applied to the catheter during retraction contributed to the balloon detachment from the catheter.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.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 following an angioplasty procedure in a subclavian central stenosis, the pta balloon catheter allegedly could not be retracted through the 7fr sheath.The balloon and sheath were removed as a single unit and 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: 6521069
• Report Number: 2020394-2017-00365
• Device Sequence Number: 808916
• Product Code: LIT
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694(17)200303(10)93PB0282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/15/2017

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: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 66