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

Model Number	U357554
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2017
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 upon opening the inner packaging an alleged break occurred at the middle of the catheter shaft.Another balloon was used to perform the procedure.There was no patient contact.
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.Conclusion: the device was returned.A visual inspection found a complete catheter detachment in the outer catheter.Therefore, the investigation is confirmed for detachment of the catheter.The user likely perceived the detachment as a break.It is unknown whether handling techniques by the user as they removed the catheter from the packaging or prepped the device may have contributed to the damaged device.It is unlikely that the detachment is manufacturing related, as a 100% visual inspection for catheter kinks and blade nicks is performed.Based upon the available information a definitive root cause has not been determined.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Do not continue to use the balloon catheter if the catheter shaft has been bent or kinked.Potential adverse reactions the complications that may result from a peripheral balloon dilatation procedure include: additional intervention.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 upon opening the inner packaging an alleged break occurred at the middle of the catheter shaft.Another balloon was used to perform the procedure.There was no patient contact.

• 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: 6931734
• Report Number: 2020394-2017-01300
• Device Sequence Number: 699042
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/21/2017

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: 05/31/2020
• Device Model Number: U357554
• Device Catalogue Number: U357554
• Device Lot Number: CMBT0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1