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

Model Number	CRUOS106
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919); Material Deformation (2976); Patient Device Interaction Problem (4001); Activation Problem (4042)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Injury (2348); Blood Loss (2597)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date: 03/2021).
Event or Problem Description
It was reported that during treatment of a 150 cm chronic total occlusion in the posterial tibial artery via common femoral access, antegrade approach, the recanalization catheter allegedly became stuck with the guidewire after 57 seconds of activation.It was further reported that when the catheter was activated to be removed, it perforated the vessel.The catheter and guidewire were removed as one unit and found damaged.Reportedly, the procedure was completed with diamondback atherectomy and pta balloon angioplasty to resolve the bleeding caused by vessel perforation.The patient is stable post-procedure.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history report was conducted and it was determined that a device history record (dhr) review was required.The lot met all release criteria.A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one crosser 14s cto recanalization catheter was returned for evaluation.Visual evaluation of the sample revealed no anomalies to the saline hub or transducer handle.Slight deformation was noted to the distal tip and at the catheter connection to the distal tip; this is most likely due to the reported perforation issue, however, the investigation is inconclusive for perforation as not enough objective evidence has been provided to confirm this alleged failure.The crosser was connected to an in-house crosser generator and flowmate without issue; the device activated and misted without issue and no leaks were noted.The distal tip of the catheter was pressed against one end of a plaster tile, and was able to penetrate the tile with no issues.However, activation started out strong, but then weakened.Material separation was noted between the outer catheter and the distal tip of the sample post-functional testing.Therefore, the investigation is confirmed for material separation and activation problem.The root cause could not be determined based upon available information.Labeling 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 during treatment of a 150 cm chronic total occlusion in the posterial tibial artery via common femoral access, antegrade approach, the recanalization catheter allegedly became stuck with the guidewire after 57 seconds of activation.It was further reported that when the catheter was activated to be removed, it perforated the vessel.The catheter and guidewire were removed as one unit and found damaged.Reportedly, the procedure was completed with diamondback atherectomy and pta balloon angioplasty to resolve the bleeding caused by vessel perforation.The patient is stable post-procedure.

• 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: 9429147
• Report Number: 2020394-2019-05293
• Device Sequence Number: 10880043
• Product Code: PDU
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/27/2020

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: CRUOS106
• Device Catalogue Number: CRUOS106
• Device Lot Number: GFDQ2954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/27/2020
• 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: 58 YR
• Patient Weight: 91