MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS BRIDGE OCCLUSION BALLOON

Model Number 590-001

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth unavailable.Patient weight unavailable.Device evaluation: completed on (b)(6) 2018.A kink was observed in tubing of device, underneath the proximal side of the balloon.0.035" guide wire successfully ran through the length of device from distal to proximal.Small resistance felt on the distal end of the leur hub, but guide wire still successfully passed through the full length.Biological material observed within the length of the tubing.Air was used to attempt inflation of the balloon, but balloon inflated only to approximately half capacity and would not inflate any further.Water was then used to inflate balloon; the balloon inflated almost fully and then a leak was identified approximately 1 1/4 inches from the most proximal band.The hole in the balloon appears to be a small pin hole.Biological material was observed, running into the balloon from tubing, with the flow of water.

Event Description

Preparations for a procedure commenced involving the prophylactic staging and inflation of a spectranetics bridge occlusion balloon.A good position was located within the svc (superior vena cava) and the balloon was inflated, adequate occlusion was confirmed via fluoroscopy, and then was deflated.During deflation of the balloon, the team determined there was a hole in the bridge balloon.The md speculated that the ij (intra jugular) sheath used in the procedure ruptured the balloon.Another bridge balloon was placed on the wire and the case was completed successfully.This report is being submitted due to the potential for serious injury or death if rupture of the bridge (rescue device) balloon were to recur.

Manufacturer Narrative

Method and result code added to reflect results of additional device evaluation additional device evaluation: on 25 may 2018, the bridge device was imaged using a scanning electron microscope.The photos showed that the external surface of the bridge balloon was mechanically damaged, which was the catalyst for failure of the device (reported initially as a hole in the balloon).

Manufacturer Narrative

Expiration date corrected from 7/9/2018 to 7/10/2018, after the device''s lot history record was available for review on 3/29/2018.

• Brand Name: SPECTRANETICS BRIDGE OCCLUSION BALLOON
• Type of Device: BRIDGE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7367723
• MDR Text Key: 103693315
• Report Number: 1721279-2018-00035
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): Y
• PMA/PMN Number: K153530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/10/2018
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN18A10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• 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: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO CONCOMITANT DEVICES LISTED IN REPORT
• Patient Outcome(s): Other
• Patient Age: 48 YR