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

Model Number	U3513068
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
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 the pta balloon allegedly ruptured (atm unknown) and detached.It was further reported that an embolectomy catheter was used to retrieve the detached balloon.Upon removal of the balloon segment, the patient's blood flow was established and the procedure was completed.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.This is the only complaint reported to date for this lot number and failure mode.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 6mm x 80mm balloon.The device was returned as a partial segment, consisting of the hubs, shaft, and the proximal base of the balloon.The device was examined under magnification (10x) and a complete circumferential rupture in the balloon was observed 8.0cm from the glue joint.A complete circumferential break in the inner lumen was noted 0.8cm from the proximal glue joint.The proximal marker band was still attached to the inner lumen.The edges of the rupture and the inner catheter detachment were examined under microscopic magnification and were observed to be jagged.The segment containing the distal end of the balloon and distal tip were not returned.No other anomalies were noted to the returned device.Functional/performance evaluation: no functional testing could be performed due to the returned sample condition (e.G.Balloon detachment, rupture).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: a visual inspection found a complete circumferential rupture to the balloon, and a complete detachment of the distal end of the balloon and catheter.Therefore, the investigation is confirmed for a circumferential rupture, and balloon and catheter 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.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 (b)(4).
Event or Problem Description
It was reported that the pta balloon allegedly ruptured (atm unknown) and detached.It was further reported that an embolectomy catheter was used to retrieve the detached balloon.Upon removal of the balloon segment, the patient's blood flow was established and the procedure was completed.There was no reported patient injury.

• 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: 6605285
• Report Number: 2020394-2017-00545
• Device Sequence Number: 19081315
• Product Code: LIT
• UDI-Device Identifier: 00801741093197
• UDI-Public: (01)00801741093197(17)190731(10)CMAV0387
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 07/31/2019
• Device Model Number: U3513068
• Device Catalogue Number: U3513068
• Device Lot Number: CMAV0387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 69