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

Model Number	CRU14SA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during treatment of calcified lesion, the recanalization catheter allegedly overheated.Reportedly, the recanalization catheter was removed from the patient without any issue.It was further reported that catheter and guidewire were used to cross the lesion.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment of calcified lesion, the recanalization catheter allegedly overheated.Reportedly, the recanalization catheter was removed from the patient without any issue.It was further reported that catheter and guidewire were used to cross the lesion.There was no reported patient injury.
Additional Manufacturer Narrative
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.
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 and failure mode.Investigation summary: one crosser 14s was returned for evaluation.No anomalies were visually identified on the returned device.The device was functionally tested using an in-house generator and flowmate.The device was able to produce vibrations throughout the entire length of the catheter.Misting was observed exiting the distal tip.The distal tip of the catheter was pressed against one end of a plaster tile for five minutes, and was able to penetrate the tile with no issues.No over heating was noted.The catheter passed all functional testing.Therefore, the investigation is unconfirmed for the alleged overheating issue.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors 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.
Event or Problem Description
It was reported that during treatment of calcified lesion, the recanalization catheter allegedly overheated.Reportedly, the recanalization catheter was removed from the patient without any issue.It was further reported that catheter and guidewire were used to cross the lesion.There was no reported patient injury.

• 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: 8180117
• Report Number: 2020394-2018-02220
• Device Sequence Number: 11289010
• Product Code: PDU
• UDI-Device Identifier: 10801741125567
• UDI-Public: (01)10801741125567
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 04/17/2019

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 Model Number: CRU14SA
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFCV2053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 03/22/2019; 04/15/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 04/02/2019; 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 100