MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS BRIDGE OCCLUSION BALLOON; 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	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Device lot number, expiration date unk.The device was not returned to the manufacturer, thus no investigation could be completed.Device manufacture date unk because lot number unk.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.Prior to the procedure, a spectranetics bridge occlusion 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 positioned in the superior vena cava (svc).It was then prophylactically inflated with contrast mixture within the patient.Upon deflation of the balloon, blood was observed in the 60 cc syringe.The bridge balloon was then removed from the patient's body.Upon observation of the balloon outside the body, it was determined that the balloon had torn in some way.Another bridge balloon was used, and the case was completed with no reported patient harm.There was a temporary wire present within the vasculature at the time of bridge balloon inflation.This report captures the bridge balloon which was observed to be torn, with the potential for injury with recurrence.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 22 feb 2022.G3): the device evaluation and investigation were completed on 21 mar 2022.H3): device evaluation: the bridge device was evaluated by a cross functional team.The device was returned in two pieces.The device was torn approximately 110 cm from its distal tip, approximately 5 mm distal of the proximal cone transition.The torn pieces matched, confirming there were no missing portions of the balloon.The device''s marker bands were present, intact and in good condition.Biologics were seen in both the guide wire and balloon lumens.Threading an 0.035 guide wire through the guide wire lumen, the device is fully patent.Water could not get through the balloon lumen due to biologics.Extensive microscopic examination of the torn area was performed.The morphological appearance of the balloon's' surface and edge suggests the damage was induced by an external influence and not as the result of a defect during manufacturing.Longitudinal damage was present, likely a precursor to the tear.The evidence suggests that the balloon came in contact with an object of sufficient hardness while moving, resulting in the jagged and serrated surface damage.This damage was initially superficial but when the surface was breached, likely the balloon got caught, resulting in a circumferential tear due to a weakening of the structural integrity of the balloon.Further information stated the device was inflated with only 25 cc at the time of prophylactic staging, confirming the balloon was not over-inflated.There was a temporary pacing wire present within the vasculature in the same area as the balloon, but no heavy calcification present that would compromise the balloon.Based on the conclusion of the investigation, it cannot be determined what external object caused the balloon damage.However, this failure has been determined to be procedure related, due to the damage likely caused by an external object.

• Brand Name: SPECTRANETICS BRIDGE OCCLUSION BALLOON
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13486658
• Report Number: 1721279-2022-00023
• Device Sequence Number: 5211307
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: 00813132024840
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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 Model Number: 590-001
• Device Catalogue Number: 590-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT 1688 RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL LDA230 RV PACING LEAD
• Patient Age: 72 YR
• Patient Sex: Male