MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number PV41340

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/12/2018

Event Type  malfunction  

Event Description

The connection piece had a bent prong and would not plug in.A new jetstream had to be opened to complete the procedure.Product had patient contact but no patient harm.Product is available to be returned to the manufacturer.Manufacturer response for jetstream catheter, (brand not provided) (per site reporter).Vendor rep plans to pick up the product for evaluation.

• Brand Name: JETSTREAM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8150205
• MDR Text Key: 129901767
• Report Number: 8150205
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PV41340
• Device Catalogue Number: PV41340
• Device Lot Number: 22470930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA