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

Catalog Number	CRU14SA
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one crosser catheter was returned for evaluation.The device was returned with a complete circumferential break in the strain relief and outer catheter, exposing the core wire.Functional testing of the returned device could not be performed due to sample condition.The alleged crack most likely was the identified break.Therefore, the investigation will be confirmed for a break based on returned condition.The investigation is inconclusive for the alleged leak, as functional testing could not be performed.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during the saline flush portion of the out of body test for a recanalization catheter, the distal end of the y-body allegedly leaked saline and a crack was identified on the y-body.Reportedly, another recanalization catheter was used to complete the procedure.There was no patient contact.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7643876
• Report Number: 2020394-2018-00999
• Device Sequence Number: 1781592
• Product Code: PDU
• UDI-Device Identifier: 10801741125567
• UDI-Public: (01)10801741125567
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFCN1603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1