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

Model Number	U357584
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).Device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured and detached.Further reported that the physician removed the detached piece of balloon.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured at 18 atm.It was further reported that the balloon allegedly detached and the detached piece of balloon was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned to the manufacturer for evaluation.However, one photo was reviewed.The photo shows the detached part of the catheter along with the portion of the ruptured balloon (compound rupture) attached to it.The ruptured balloon appears bloody.No other specific anomalies noted.Therefore based on the submitted photo, compound balloon rupture and balloon detachment can be confirmed since the detached catheter and ruptured balloon can be seen.Therefore the investigation can be confirmed for the reported balloon rupture since a compound rupture was noted on the balloon.The investigation can be confirmed for the reported detachment since the device is noted to be detached distally.A definitive root cause for the alleged compound balloon rupture and detachment could not be determined based upon the provided information.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 01/2024), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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 bd.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one photo was reviewed.The photo shows the detached distal part of the catheter exposing the inner guide wire lumen along with the portion of the ruptured balloon (circumferential rupture) attached to it.The ruptured balloon appears bloody.No other specific anomalies noted.Therefore based on the submitted photo, balloon rupture and balloon detachment can be confirmed since the detached catheter and ruptured balloon can be seen.One ultraverse035 pta dilatation catheter in two segments has returned for evaluation.On the visual evaluation of the device the segment 1 consist detached distal end of the catheter exposing the inner guide wire lumen and circumferentially ruptured balloon.Segment 2 consist of the remaining part of the catheter.Only the proximal marker band was present.All the anomalies noted on the microscopic observation.No other specific anomalies noted.No functional testing performed due to the condition device.Therefore, the investigation was confirmed for the reported balloon rupture as the returned device has circumferential rupture.The investigation was also confirmed reported detachment as the catheter retuned in 2 segments for evaluation.A definitive root cause for the alleged circumferential balloon rupture and detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 01/2024).H11: section a through f ¿ the information provide by bd represents all 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 18 atm.It was further reported that the balloon allegedly detached.Reportedly, another balloon was inflated to remove the detached piece through the introducer.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12711482
• Report Number: 2020394-2021-01919
• Device Sequence Number: 17337052
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2021

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 Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMFP0198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 12/20/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/19/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown