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

Catalog Number CRE14S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes 12 malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment issues.This information was received from various sources.Of the 12 events, 2 did not involve patients, and 10 involved patients with no patient consequences.One patients age was reported as (b)(6) years old.Three patients were reported to be male and one patient was reported to be female.The age, weight, and gender were not reported for the remaining patients.

Manufacturer Narrative

H10: out of the reported 12 malfunctions, 2 devices were returned for evaluation.The lot number was provided all malfunctions; therefore, a lot history review was performed.For the two devices returned, detachment was confirmed for one device.Investigation identified detachment for the other device.For the remaining 10 malfunctions, samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive for these devices.A definitive root cause could not be determined.The devices were labeled for single use.H10: g4, d4: (gfds3199, gfdu3094, gfdu0339, gfdu0364, gfdv0746, gfct1851, gfdv0732, gfcr1474) h11: g1, h6 (results, 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 12 malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment issues.This information was received from various sources.Of the12 events, 2 did not involve patients, and 10 involved patients with no patient consequences.One patients age was reported as 82 years old.Three patients were reported to be male and one patient was reported to be female.The age, weight, and gender were not reported for the remaining patients.

Manufacturer Narrative

H10: the lot number was provided all malfunctions; therefore, lot history reviews were performed.Out of the reported 12 malfunctions, 2 devices were returned for evaluation.One malfunction is confirmed for detachment.The other malfunction is confirmed for material separation and material cut and unconfirmed for detachment.For the remaining 10 malfunctions, samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunctions was inconclusive for these devices.A definitive root cause could not be determined.The devices were labeled for single use.H10: g4, d4: (gfds3199, gfdu3094, gfdu0339, gfdu0364, gfdv0746, gfct1851, gfdv0732, gfcr1474).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 12 malfunctions.A review of the reported informations indicated that model cre14s recanalization catheter allegedly experienced detachment issues.This information was received from various sources.Of the 12 malfunctions, 2 did not involve patients, and 10 involved patients with no patient consequences.One patients age was reported as 82 years old.Three patients were reported to be male and one patient was reported to be female.The age, weight, and gender were not reported for the remaining patients.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9975197
• MDR Text Key: 188726744
• Report Number: 2020394-2020-03001
• 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,Followup
• Report Date: 10/27/2020

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 Operator: No Information
• Device Catalogue Number: CRE14S
• Device Lot Number: GFDR3323, GFCN1980, GFDU2131
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 09/30/2020
• Supplement Dates FDA Received: 07/10/2020; 10/27/2020
• Patient Sequence Number: 1