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

Model Number	590-001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's weight unavailable.Relevant tests/laboratory data unavailable.Attempts to obtain the information have not been successful.Other relevant history unavailable.Attempts to obtain the information have not been successful.The bridge balloon was returned to the manufacturer on 15 june 2021.A supplemental mdr will be submitted once the device evaluation and investigation have been completed.
Event or Problem Description
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to cied system/pocket infection.Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically inflated to ensure superior vena cava (svc) occlusion in the event that an emergency occurred during the procedure and required use of the bridge balloon.The bridge balloon was placed on the guide wire and was reportedly positioned in the superior vena cava (svc)/right atrial (ra) junction.It was then prophylactically inflated with contrast mixture within the patient and when inflated, the bridge balloon reportedly slipped down into the right atrium.Subsequently, while deflating the bridge balloon in order to ''stage'' the device within the patient for its use if necessary, it was noticed that blood was appearing in the 60cc syringe used for deflating the balloon.It was decided at that time to remove the bridge balloon from the patient's body.When the bridge balloon was out of the patient, it was re-inflated again, and there was a hole noted in the middle of the balloon.Another device was used, and the case was completed successfully 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 were to recur during an emergency.
Additional Manufacturer Narrative
G3): device evaluation and investigation were completed on 26 july 2021.H3): the device evaluation and investigation were completed.H6): added codes 3243, and 4315.Device evaluation: the device was evaluated and investigation completed by a cross functional team.Biologics were seen within the balloon hub and in the balloon.Using a syringe, water was fed through the balloon hub and into the balloon.After approximately 25cc of water was fed into the balloon, water was seen dripping out through a hole in the balloon.Under magnification, a slash shaped hole approximately 1.2mm in length was seen.There appeared to be scratches in the balloon leading up the hole.Further imaging was performed with use of a scanning electron microscope (sem).Based on the evaluation, complaint narrative, and images from the sem, the device was likely damaged during use, from an external source.However, the cause of the hole cannot be established.

• 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: 12050111
• Report Number: 1721279-2021-00114
• Device Sequence Number: 14368024
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: (01)00813132024840(17)210904(10)FMN19J03A
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 09/04/2021
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN19J03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RA AND RV LEADS, MANUFACTURER AND MODEL UNK
• Patient Age: 74 YR