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

Model Number	CRUS6A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.Expiration date (03/2020).
Event or Problem Description
It was reported that after approximately five minutes activation time in a calcified left sfa via groin, the tip of the recanalization catheter was allegedly detached from the catheter and "remain" in the patient.It was further reported that stent was placed to secure the tip to the artery wall.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was required.The lot met all release criteria.Investigation summary: the device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported tip detachment issue.Per the reported event details, the physician activated the catheter for more than five minutes.Per the ifu "do not exceed 5 minutes of activation time as crosser catheter malfunction may occur.If 5 minutes of activation time is achieved exchange for a second crosser catheter before resetting the crosser generator." therefore, the extended activation time could have contributed to the alleged tip detachment.However, the definitive root cause is unknown.Label review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that after approximately five minutes activation time in a calcified left sfa via groin, the tip of the recanalization catheter allegedly detached from the catheter and then remained in the patient.It was further reported that a stent was placed to secure the tip to the artery wall.

• 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: 8181217
• Report Number: 2020394-2018-02225
• Device Sequence Number: 13877008
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFCQ1868
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113