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

Model Number	U415054RX
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.However, photos were provided for 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.It was further reported that the device allegedly had a retraction problem.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2023), g3.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.It was further reported that the device allegedly had a retraction problem and detachment issue.Reportedly, the patient had occlusive dissection due to balloon rupture.The patient status was unknown.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.It was further reported that the device allegedly had a retraction problem and detachment issue.Reportedly, the patient had occlusive dissection due to balloon rupture.The patient status was unknown.
Additional Manufacturer Narrative
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 ultraverse rx pta dilatation catheter has returned for evaluation.On the visual evaluation the catheter returned with multiple kinks throughout the device.Partially detached balloon was not returned for evaluation and compound rupture was noted to the device which returned at the proximal end of the catheter, inner gw lumen exposed with no marker bands present.Microscopic observation also confirms the allegation.No other anomalies noted.No functional evaluation performed due to the condition of the device.Four photos was reviewed.The first photo shows the outside packaging label of the device.The second photo shows the detached and separated balloon portion from the catheter.The third and fourth photos show the compound ruptured, and fully detached balloon.Therefore, based on the photo review, the reported balloon rupture and detachment of device can be confirmed.Therefore, the investigation was confirmed for the reported balloon rupture as balloon is noted to have been ruptured circumferentially form the catheter in the photos submitted.The investigation is also confirmed for the detachment of device as the balloon ruptured circumferentially and detached from the catheter.However, the investigation is inconclusive for the reported retraction issue as this could not be evaluated for due to the condition of the device.A definitive root cause for the balloon rupture, retraction issue and detachment of device could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 02/2023.Section a through f - the information provided by bd 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 bd.

• Brand Name: ULTRAVERSE RX 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: 11384714
• Report Number: 2020394-2021-00355
• Device Sequence Number: 19865053
• Product Code: LIT
• UDI-Device Identifier: 00801741057793
• UDI-Public: (01)00801741057793
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131199
• 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): 03/24/2021

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 Model Number: U415054RX
• Device Catalogue Number: U415054RX
• Device Lot Number: CMEQ0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/09/2021; 05/24/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/05/2021; 05/27/2021
• 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: Life Threatening; Other