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

Model Number	590-001
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient weight unavailable.Device evaluation: the device was returned to the manufacturer and evaluated by a cross functional engineering team on 30 july 2020.The device tip appeared to be in good condition with no kinks, wrinkles or other damage.There was material identified in the balloon port.No damage was identified to the extruded tubing, and the skived area in the hub and proximal adhesive looked to be in good condition.The team attempted to load an 0.035 guide wire through the tip of the device; material appeared in the lumen and increased resistance was noted.The guide wire stopped in the area of the strain relief of the device (the strain relief is just distal to the hub of the device, and is designed to prevent kinks in the area).Next, the team attempted to load an 0.018 guide wire.This size guide wire successfully passed through the strain relief area and was able to retrieve the material seen at the balloon port.The team again attempted to load an 0.035 guide wire again from both the proximal and distal ends of the device; the guide wire would not pass through the device, resistance was felt under the strain relief.The strain relief was then removed for examination.Excessive adhesive was found at the distal end of the strain relief.The bridge balloon is produced and assembled by the manufacturer's supplier and this failure has been determined to be production process related.
Event or Problem Description
A lead extraction procedure was scheduled to remove one right ventricular (rv) lead due to non function.Prior to beginning, a spectranetics bridge occluding balloon was being prepped to be used in the event an emergency occurred during the procedure.However, while attempting to place the bridge balloon on the guide wire, it would not thread onto the wire.The wire reportedly stopped approximately 2-3 inches from the device''s tip.The bridge balloon was then turned around to see if the wire would thread through the opposite way but stopped in approximately the same area.A new bridge balloon was obtained, and successfully placed on the wire.The procedure was completed with no reported patient harm.This report is being submitted due to this failure contributing to a serious injury if it were to recur during an adverse event.

• 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: 10370911
• Report Number: 1721279-2020-00156
• Device Sequence Number: 10969013
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)220601(10)FMN20E27A
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153530
• 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
• Report Date (Section B): 07/08/2020
• Report Date (Section F): 01/01/2005

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: 06/01/2022
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN20E27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/05/2020
• 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: Other
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005