MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY; CATHETER, PERCUTANEOUS

Model Number	8575
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aware date used as event date, as no event date was reported.(b)(4).
Event or Problem Description
It was reported that a hole in the package occurred.A model-6f runway was selected for use.During preparation, when the device was removed from the box, it was noted that there was a puncture hole in the catheter packaging.No patient involvement were reported.
Event or Problem Description
It was reported that a hole in the package occurred.A model-6f runway was selected for use.During preparation, when the device was removed from the box, it was noted that there was a puncture hole in the catheter packaging.No patient involvement were reported.
Additional Manufacturer Narrative
Aware date used as event date, as no event date was reported.(b)(4).Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a runway guide catheter in the sterile pouch and the original packaging.Analysis of returned product revealed that the outside package was visually inspected for damage.There was a puncture in the packaging which went completely through the box and the contents inside.The sterile pouch was inspected for damage and showed the same puncture.The catheter shaft showed no damage.However, sterility would have been compromised.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8541434
• Report Number: 2134265-2019-04169
• Device Sequence Number: 14064387
• Product Code: DQY
• UDI-Device Identifier: 08714729478966
• UDI-Public: 08714729478966
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060167031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1