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 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device now available for evaluation on 4 may 2018.Device evaluation: evaluation completed on 10 may 2018.A kink was present at the distal end of the device from return packaging.Patency was checked with 0.035" guide wire.Distal to hub: resistance was noted at hub from tube to hub, but guide wire does pass.Red biological material was present.A 60 ml syringe was used to fill the balloon with air.At first the device slowly inflated but was failing to expand.Filled a tub with water to inflate balloon under water; results were bubbles seen at the proximal end of the balloon on the cone transition.Device re-evaluation completed on 25 may 2018.The device was imaged using a scanning electron microscope.The photos showed the external surface of the balloon was mechanically damaged, which was the catalyst for failure (initial complaint stated that a small leak was noted on the balloon as the physician and scrub tech chose to inflate the balloon for hands-on experience with deployment post-procedure; it was also reported that the balloon had been sitting on the scrub table with suture needles and other open supplies).

• Brand Name: SPECTRANETICS BRIDGE OCCLUSION BALLOON
• Type of Device: BRIDGE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO
• MDR Report Key: 7485407
• MDR Text Key: 313030381
• Report Number: 1721279-2018-00055
• 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
• Report Date: 01/01/2005,04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/22/2018
• Device Model Number: 590-001
• Device Catalogue Number: 590-001
• Device Lot Number: FMN17L22A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• 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: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Treatment: NO CONCOMITANT DEVICES LISTED IN REPORT
• Patient Outcome(s): Other
• Patient Age: 65 YR