MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER

Catalog Number CRE14S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for ten out of ten malfunctions; therefore, a lot history review is currently being performed.The seven devices were not returned, therefore the investigation is inconclusive for those malfunctions.For the remaining three malfunctions, the devices were provided for review as well as two photos were provided.The company is still investigating the issue at this time.Corporate lot no (gfds0837, gfdv2750, gfdt2529, gfdw2700, gfdv0731, gfdw3565).

Event Description

This report summarizes ten malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced tip detachment.This information was received from various sources.Of the ten malfunctions, ten involved patients with no patient consequences.Five patients ages ranged from 67-86 years of age and three patients' weights ranged from 60-82 kg's.Of the ten reported patients, two are male and three are female.Age, weight, and gender of the remaining patients were not provided.

Manufacturer Narrative

H10: the lot number was provided for ten out of ten malfunctions; therefore, a lot history review was performed.Seven devices were not returned, therefore the investigation is inconclusive for detachment.Additionally one of those seven malfunctions was also inconclusive for material deformation.For the remaining three malfunctions, the devices were returned as well as two photos were provided for two malfunctions.Two malfunctions were confirmed for material separation and for one malfunction was unconfirmed for the reported tip detachment.H10: g4, d4 corporate lot no (gfds0837, gfdv2750, gfdt2529, gfdw2700, gfdv0731, gfdw3565).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 ten malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced tip detachment.This information was received from various sources.Of the ten malfunctions, ten involved patients with no patient consequences.Five patients ages ranged from 67-86 years of age and three patients' weights ranged from 60-82 kg's.Of the ten reported patients, two are male and three are female.Age, weight, and gender of the remaining patients were not provided.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10295882
• MDR Text Key: 199490360
• Report Number: 2020394-2020-04665
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125420
• UDI-Public: (01)10801741125420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CRE14S
• Device Lot Number: GFDV0731, GFDU3094, GFCY3359
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1