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

Model Number 0284514

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

For one of the two reported malfunctions, the device was returned to bd and identified for the material rupture.The other sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction is inconclusive for the second device.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 0284514 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from various sources.Of the 2 material ruptures, 2 involved patients with no patient consequences.There was no provided patient information.

Manufacturer Narrative

H10: the lot number for both of the reported malfunctions was not provided, therefore a lot history review was not performed.For one of the two reported malfunctions, the device was returned to bd and identified for the material rupture.The other sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction is inconclusive for the second device.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H10: g4.H11: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.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 0284514 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from various sources.Of the 2 material ruptures, 2 involved patients with no patient consequences.There was no provided patient information.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 0284514 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from various sources.Of the 2 material ruptures, 2 involved patients with no patient consequences.There was no provided patient information.

Manufacturer Narrative

H10: of the two reported malfunctions, the lot numbers were not provided and a lot history review could not be performed.For one of the malfunctions the sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction is inconclusive for the second device.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.One of the reported malfunctions was reassessed and determined to be no longer reportable.H11: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.

Manufacturer Narrative

H10: of the 2 reported malfunctions, one of the reported malfunctions was reassessed and determined to be no longer reportable.H10: the lot number for the device was not provided; therefore, a lot history review could not be performed.The device was not returned to the manufacturer for 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 device is labeled for single use.John t.Saxon, keith b.Allen, david j.Cohen, brian whisenant, jason ricci, and ilie barb (2019).Complications of bioprosthetic valve fracture as an adjunct to valve-in-valve tavr.Structural heart, 3(2), 92¿99.Doi: (b)(4).(product catalog no), g1, h6(conclusion).H11: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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model unknown true pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender were not provided for the patient.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION 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 NY 12804
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9576566
• MDR Text Key: 174601678
• Report Number: 2020394-2020-00188
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741097478
• UDI-Public: (01)00801741097478
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2022

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
• Device Model Number: 0284514
• Device Catalogue Number: UNKNOWN TRUE
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/14/2020; 03/24/2020; 06/30/2022
• Supplement Dates FDA Received: 01/14/2020; 04/02/2020; 07/26/2022
• Type of Device Usage: A
• Patient Sequence Number: 1