MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER

Model Number 590-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Date of event unavailable.Device lot, expiration date unavailable.Therapy date unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced (lead location and indication unknown).Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically ''staged'' within the patient's inferior vena cava (ivc).In the event that an emergency occurred during the procedure, the bridge balloon could then be positioned and inflated within the superior vena cava (svc) to provide occlusion of the svc as a rescue measure.There is no report of case detail, and no report of any patient injury.It was not reported that the bridge balloon was used.It was reported that when the bridge balloon was removed from the body after the procedure, the physician noted a significant thrombus present on the bridge balloon.There was no reported patient harm.The manufacturer became aware of this event from a physician presentation and from subsequent conversations with the physician and manufacturer.

Manufacturer Narrative

This is no longer a reportable event.An email was sent to the manufacturer on (b)(6) 2020, from the physician who gave the presentation regarding thrombus on the bridge balloon and who reported this event to the manufacturer.The physician reported that after further investigation into his data, it has been determined that in this event, no thrombus occurred during this procedure.With this additional information from the physician, this subsequent mdr is being submitted to correct the information initially reported.Mdr 1721279-2020-00073 is no longer valid since no adverse event occurred.

Event Description

Subsequent to receiving the initial data from the physician regarding this event, the manufacturer received word from the physician that he could not initially complete his investigation for this specific procedure due to covid-19 crisis delay.As a result of this, the initial mdr (1721279-2020-00073) was conservatively submitted, reporting the event based on the initial data provided.Then, upon the physician''s investigation completion, it has been confirmed that no adverse event had occurred; therefore the event is now non reportable.A confirmation email was sent to the manufacturer on (b)(6) 2020, from the physician who gave the presentation regarding thrombus on the bridge balloon and who reported this event to the manufacturer.The physician reported that after completion of the investigation into this event, it has been determined that in this event, no thrombus occurred during this procedure.With this additional information from the physician, this subsequent mdr is being submitted to correct the information initially reported.Mdr 1721279-2020-00073 is no longer valid since no adverse event occurred.The initial mdr read as follows: a lead extraction procedure commenced (lead location and indication unknown).Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically ''staged'' within the patient''s inferior vena cava (ivc).In the event that an emergency occurred during the procedure, the bridge balloon could then be positioned and inflated within the superior vena cava (svc) to provide occlusion of the svc as a rescue measure.There is no report of case detail, and no report of any patient injury.It was not reported that the bridge balloon was used.It was reported that when the bridge balloon was removed from the body after the procedure, the physician noted a significant thrombus present on the bridge balloon.There was no reported patient harm.The manufacturer became aware of this event from a physician presentation and from subsequent conversations with the physician and manufacturer.

• Brand Name: SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER
• Type of Device: BRIDGE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9878430
• MDR Text Key: 186722613
• Report Number: 1721279-2020-00073
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00813132024840
• UDI-Public: 00813132024840
• Combination Product (y/n): Y
• PMA/PMN Number: K153530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEAD, LOCATION AND MANUFACTURER UNKNOWN
• Patient Outcome(s): Other