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

Model Number	U35130610
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured between 16 - 18 atm on the second inflation, subsequently the distal portion of the balloon allegedly detached from the catheter shaft.Reportedly, the health care provider deployed a covered stent to pin the detached balloon segment to the vessel wall.The procedure was concluded, and no further treatment was provided.There was no reported impact or consequence to the patient.
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 not returned, however four electronic photos were provided for review.The photos show a complete circumferential rupture in the barrel of the balloon, as well as detachment of the distal portion of the balloon and the distal end of the inner guidewire lumen.Therefore, the investigation is confirmed for the reported rupture and detachment.The balloon rupture likely contributed to the balloon and catheter detachment.However, the definitive root cause for the balloon rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Photo review: four electronic photos were reviewed.The first photo shows a segment of an ultraverse 035 device laying on product packaging; the product label is visible in the photo and matches the reported product information in trackwise.The photo shows the distal portion of the outer catheter and balloon; a complete circumferential rupture is noted in the balloon, with the inner guidewire lumen extending distally, out of the rupture.A complete detachment of the inner guidewire lumen is noted as well.The second and third photos show the same rupture as in the first photo; however, the detachment of the inner guidewire lumen is not visible.The fourth photo shows the same rupture and detachment as in the first photo.The detached distal segment of the device, was not visible in any of the reviewed photos.Based on the photo review, the investigation can be confirmed for a complete circumferential balloon rupture and for balloon and catheter detachment.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.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured between 16 - 18 atm on the second inflation, subsequently the distal portion of the balloon allegedly detached from the catheter shaft.Reportedly, the health care provider deployed a covered stent to pin the detached balloon segment to the vessel wall.The procedure was concluded, and no further treatment was provided.There was no reported impact or consequence to the patient.

• Brand Name: ULTRAVERSE 035 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: 6916340
• Report Number: 2020394-2017-01282
• Device Sequence Number: 1181661
• Product Code: LIT
• UDI-Device Identifier: 00801741093203
• UDI-Public: (01)00801741093203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: U35130610
• Device Catalogue Number: U35130610
• Device Lot Number: CMAX0128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 63