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

Catalog Number	CRUS6A
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no images were provided to the manufacturer.The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.( expiration date: 06/2020).
Event or Problem Description
It was reported that during the operation test of the device before use on the patient, saline allegedly leaked out of the hub of the catheter.Another device was used to complete the procedure.There was no reported patient contact.
Event or Problem Description
It was reported that during the operation test of the device before use on the patient, saline allegedly leaked out of the hub of the catheter.Another device was used to complete the procedure.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been 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.Investigation summary: one crosser s6 catheter was returned for evaluation.The catheter was connected to an in-house generator and injector.A leak was identified near the strain relief.A partial circumferential break to the outer catheter was identified.The investigation is confirmed for leak due to a break in the outer catheter.The partial circumferential break led to the reported catheter leak.It is possible the manner in which the device was unclipped from the packaging hoop contributed to the outer catheter break; however, the definitive root cause is unknown.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.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8127046
• Report Number: 2020394-2018-02154
• Device Sequence Number: 2364245
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/09/2019

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 Catalogue Number: CRUS6A
• Device Lot Number: GFCT0681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR