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

Model Number	CRUOS106
Medical Device Problem Codes	Fracture (1260); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The device was not returned to bd for evaluation.The investigation inconclusive for overheating and fracture as no sample was provided.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106 recanalization catheter allegedly experienced over heating and a fracture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient was a 68 year old male that weighed 75 kgs.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned.The investigation reported issue was inconclusive for overheating of device and fracture.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: g1 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106 recanalization catheter allegedly experienced over heating and a fracture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient was a 68 year old male that weighed 75 kgs.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9588903
• Report Number: 2020394-2020-00257
• Device Sequence Number: 3674579
• Product Code: PDU
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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
• Operator of Device: No Information
• Device Model Number: CRUOS106
• Device Catalogue Number: CRUOS106
• Device Lot Number: GFCV2050
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1