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  

Manufacturer Narrative

Of the seven malfunctions, four did not have devices returned and are inconclusive for detachment as no objective evidence has been provided to confirm any alleged deficiency with the device.Two malfunctions have had their devices returned for evaluation and one malfunction is currently awaiting device return.The investigations of the reported malfunctions are currently underway.The devices are labeled for single use.(lot number: gfdt2529, gfdu0364, unknown).

Event Description

This report summarizes seven malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment of device.This information was received from various sources.Of the seven detachments, one did not involve a patient, and six involved patients with no consequences.One patient was reported as male and another patient was reported as female with their ages ranging from (b)(6) years-old.All other patient information was not provided.

Manufacturer Narrative

H10: of the seven malfunctions, three did not have devices returned and are inconclusive for detachment as no objective evidence has been provided to confirm any alleged deficiency with the device.Four malfunctions have had their devices returned for evaluation and one malfunction identified as a detachment and the other is currently under investigations.The devices are labeled for single use.H10: g4, d4(lot number: gfdt2529, gfdu0364, unknown).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 seven malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment of device.This information was received from various sources.Of the seven detachments, one did not involve a patient, and six involved patients with no consequences.One patient was reported as male and another patient was reported as female with their ages ranging from 75 to 84-years-old.All other patient information was not provided.

Manufacturer Narrative

H10: of the seven reported malfunctions, corporate lot number was provided for six complaints and the device history record (dhr) was performed on them, corporate lot number was not provided for the seventh complaint.Three devices were not returned and the investigation remains inconclusive for those claimed devices.Four devices were returned for evaluation and upon investigation three malfunctions were confirmed for detachment, but one was unconfirmed for detachment and confirmed for material separation.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 seven malfunctions.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment of device.This information was received from various sources.Of the seven detachments, one did not involve a patient, and six involved patients with no consequences.One patient was reported as male and another patient was reported as female with their ages ranging from 75 to 84-years-old.All other patient information was not provided.

• 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: 9591782
• MDR Text Key: 178747801
• Report Number: 2020394-2020-00296
• 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: 07/09/2020

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: GFCT1851,GFDP0655,GFDT3282
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 03/26/2020; 06/30/2020
• Supplement Dates FDA Received: 04/03/2020; 07/09/2020
• Patient Sequence Number: 1