MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	590-001
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's weight unavailable.Device evaluation: the device was returned to the manufacturer and evaluated by a cross functional team on (b)(6) 2021.The distal tip was bent, potentially from shipping the device back for evaluation.Using a bridge prep kit guide wire feeding through the proximal end, no resistance was felt, and the guide wire, feeding it through the distal tip, no resistance was felt.The guide wire was able to be fed through the entire length of the device both proximally and distally without issue.Further investigation confirmed that the guide wire used in the procedure is similar to the guide wire present within the bridge prep kit.It was also confirmed that the guide wire remained in place within the patient when this device was removed, and the guide wire reportedly advanced through the second bridge balloon without issue.The team was unable to replicate the reported complaint.
Event or Problem Description
A philips representative became aware on 09 june 2021 that during preparation for a lead extraction procedure which commenced on (b)(6) 2021 and while attempting to advance a spectranetics bridge occluding balloon over the guide wire (to be used in the event of an emergency), it was found that the bridge balloon would only advance approximately 1/3 of the way into the patient''s vessel, and was reportedly blocked within the balloon.This device was removed and another bridge balloon was successfully advanced, using the same guide wire as with the first balloon.The procedure was successfully completed with no reported patient harm.This report is being submitted due to the potential of this reported failure contributing to death or serious injury if the failure was to recur during an emergency.

• Brand Name: SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12096019
• Report Number: 1721279-2021-00122
• Device Sequence Number: 4752005
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)221020(10)FMN20K20A
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K203540
• 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
• Report Date (Section B): 06/09/2021

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: 10/20/2022
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN20K20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1