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

Catalog Number CRE14S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.A photo was provided.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.(expiration date 05/2020).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 Description

It was reported that after five minutes of activation, the distal tip of the recanalization catheter allegedly detached from the catheter in the posterior tibialis after passing the sfa lesion.It was further reported that the health care provider determined to implant a stent to secure the tip to the wall and prescribed the patient actilyse(r).There was no reported patient injury.

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 catheter returned for evaluation.Two photos were provided and reviewed.Visual inspection of the device identified the tip was detached along with a short portion of the outer shaft.The photos reveal a crosser catheter with guidewire extending from the distal portion of the catheter.The distal tip is detached from the catheter.Therefore, based on evaluation of the returned device and the photo review, the investigation is confirmed for detachment of the tip and detachment of the catheter.Per the provided event details, the device had been running for close to 5 minutes when the incident happened.The current ifu states, "do not exceed 5 minutes of activation time as crosser catheter malfunction may occur." therefore, it is possible that the device was used over the 5 minute activation, which could have contributed to the reported event.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.The current ifu (instructions for use) states: warnings and precautions: when using the crosser® catheter in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser® catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.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 (expiration date 05/2020).

Event Description

It was reported that after five minutes of activation, the distal tip of the recanalization catheter allegedly detached from the catheter in the posterior tibialis after passing the sfa lesion.It was further reported that the health care provider determined to implant a stent to secure the tip to the wall and prescribed the patient actilyse(r).There was no reported patient injury.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8140097
• MDR Text Key: 129572904
• Report Number: 2020394-2018-02172
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125420
• UDI-Public: (01)10801741125420
• Combination Product (y/n): N
• PMA/PMN Number: K161208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: CRE14S
• Device Lot Number: GFCR0875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention