MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Model Number	0244512
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2023).Device not returned.
Event or Problem Description
It was reported that during a procedure, the balloon allegedly ruptured causing trauma to the iliac artery and subsequent hemorrhage.It was further reported that the device was difficult to be retracted.The patient reportedly expired.
Event or Problem Description
It was reported that during a procedure, the balloon allegedly ruptured causing trauma to the iliac artery and subsequent hemorrhage.It was further reported that the device was difficult to be retracted.The patient reportedly expired.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The reported balloon rupture is the most likely cause of the reported difficult to remove.However, the definitive root cause for the reported balloon rupture, difficult to remove and material deformation could not be determined based upon 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: d4 (expiry date: 07/2023).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.
Event or Problem Description
It was reported that during a procedure, the balloon allegedly ruptured causing trauma to the iliac artery and subsequent hemorrhage.It was further reported that the device was difficult to be retracted.The patient reportedly expired.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos or medical records were provided for review.Per the reported event details, the removal of the ruptured balloon and sheath led to patient artery damage and hemorrhage.However, the exact cause of death was not provided.Therefore, the investigation is inconclusive as no objective evidence was provided for review.The reported balloon rupture is the most likely cause of the reported difficult to remove.However, the definitive root cause for the reported balloon rupture, difficult to remove and material deformation could not be determined based upon 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: g3.H11: d4 (unique identifier (udi) #), g1.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.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice_ ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12446061
• Report Number: 2020394-2021-01653
• Device Sequence Number: 3382815
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018(11)200828(17)230728(10)GFEU3074
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

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: 07/28/2023
• Device Model Number: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFEU3074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 02/14/2025
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/05/2021; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2020
• 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
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Male
• Patient Weight: 72 KG