MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	29417
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating peeled off.The target lesion was located in the liver area.A renegade was selected for use.During procedure, after the first session chemo drug injection in a lesion another artery selection was performed.However, the device could not be pushed as the position of the renegade is just in the tip of the rh catheter when observed under angiogram but it can't be push over.Both catheter and guidewire were then removed directly from the patient's body without any friction noted.Upon inspection, the catheter was astringent to touch as the surface was not smooth, thus it was presumed that the hydrophilic coating of renegade catheter might be peeled off during the operation.The procedure was completed with a different device.No complications reported and patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the hydrophilic coating.Under microscope analysis areas are seen where the coating has sheared off or been pushed back on itself at 60 cm and 62.5 cm.A coating bulge was seen at 45.5 cm from the tip.Stretching was also noted at 7.5 cm to 8.5 cm from the tip.Device analysis determined the condition of the returned device was consistent with the reported information.Peeling or shearing of the coating was observed.There was no evidence of any damage or irregularities contributing to the reported insertion difficulty, which could not be confirmed because the clinical circumstances could not be replicated.
Event or Problem Description
It was reported that the coating peeled off.The target lesion was located in the liver area.A renegade was selected for use.During procedure, after the first session chemo drug injection in a lesion another artery selection was performed.However, the device could not be pushed as the position of the renegade is just in the tip of the rh catheter when observed under angiogram but it can't be push over.Both catheter and guidewire were then removed directly from the patient's body without any friction noted.Upon inspection, the catheter was astringent to touch as the surface was not smooth, thus it was presumed that the hydrophilic coating of renegade catheter might be peeled off during the operation.The procedure was completed with a different device.No complications reported and patient is stable.

• Brand Name: RENEGADE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11561068
• Report Number: 2134265-2021-03743
• Device Sequence Number: 2955733
• Product Code: KRA
• UDI-Device Identifier: 08714729235125
• UDI-Public: 08714729235125
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Expiration Date: 03/29/2022
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0023710351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1