MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U3513084
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
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.
Event or Problem Description
It was reported that after a successful angioplasty procedure the pta balloon catheter allegedly got stuck inside the 5fr sheath and subsequently the bifurcation detached from the catheter shaft.Reportedly, the remaining catheter was pulled out from the sheath and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found the catheter shaft to be detached at the distal end of the bifurcate hub.Therefore, the investigation is confirmed for a catheter detachment.The definitive root cause for the detachment could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: 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/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter 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 introducer sheath/guide catheter as a single unit.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that after a successful angioplasty procedure the pta balloon catheter allegedly got stuck inside the 5fr sheath and subsequently the bifurcation detached from the catheter shaft.Reportedly, the remaining catheter was pulled out from the sheath and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the catheter shaft to be detached at the distal end of the bifurcate hub.Therefore, the investigation is confirmed for a catheter detachment.Additionally, the device was returned stuck in the user's introducer sheath.Therefore, the investigation is confirmed for the reported retraction issues.The definitive root cause for the identified detachment or retraction issue could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: 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/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter 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 introducer sheath/guide catheter as a single unit.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that after a successful angioplasty procedure the pta balloon catheter allegedly got stuck inside the 5fr sheath and subsequently the bifurcation detached from the catheter shaft.Reportedly, the remaining catheter was pulled out from the sheath and no further treatment was provided.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 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: 7273774
• Report Number: 2020394-2018-00108
• Device Sequence Number: 135624
• Product Code: LIT
• UDI-Device Identifier: 00801741094170
• UDI-Public: (01)00801741094170
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2018

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: 08/31/2019
• Device Model Number: U3513084
• Device Catalogue Number: U3513084
• Device Lot Number: CMAW0143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/13/2018; 03/19/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/16/2018; 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1