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

Model Number 45007

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

It was reported that the device was contaminated.A 2.1mm jetstream xc catheter was received at the facility.Upon review, it was discovered to have been covered in an unspecified, oil-like substance.The product box was opened and it was determined the secondary packaging that held the product was also compromised.

Event Description

It was reported that the device was contaminated.A 2.1mm jetstream xc catheter was received at the facility.Upon review, it was discovered to have been covered in an unspecified, oil-like substance.The product box was opened and it was determined the secondary packaging that held the product was also compromised.

Manufacturer Narrative

Device received and evaluated by manufacturer.Returned product consisted of a jetstream atherectomy system still in the shelf box.Visual examination revealed that the shelf box was contaminated with an unknown oily liquid.The seal on the shelf box was open.The device pouch was contaminated with the same liquid.Inspection of the remainder of the device, revealed no other damage or irregularities.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9693421
• MDR Text Key: 179505223
• Report Number: 2134265-2020-01275
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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
• Device Operator: Other
• Device Expiration Date: 08/12/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022643608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/18/2020
• Patient Sequence Number: 1