MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIVAC PERICARDIOCENTESIS KITS; WIRE, GUIDE, CATHETER

Model Number	86445
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a packing error occurred with a perivac pericardiocentesis kit.Instead of a pericardial puncture set, a pleural puncture set was included.The procedure was completed with another perivac kit and no patient complications occurred.The device was disposed of and therefore will not be returned for analysis.

• Brand Name: PERIVAC PERICARDIOCENTESIS KITS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11591520
• Report Number: 2134265-2021-04100
• Device Sequence Number: 14647730
• Product Code: DQX
• UDI-Device Identifier: 08714729333234
• UDI-Public: 08714729333234
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 02/02/2023
• Device Model Number: 86445
• Device Catalogue Number: 86445
• Device Lot Number: 0026738967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1