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

Model Number	86445
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a pericardiocentesis procedure a perivac kit was selected for use.When the physician sutured around the catheter in order to fix it to the chest, the catheter was suddenly snapped and broke.The perivac catheter was exchanged for another and the procedure was completed successfully with no patient complications.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The perivac kit was received by boston scientific for analysis.Visual inspection revealed that the catheter was broken in the middle.Additional testing under a high magnification microscope confirmed that the type of damage observed is consistent with a mechanical cut; consequently, confirming the reported complaint.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
During a pericardiocentesis procedure a perivac kit was selected for use.When the physician sutured around the catheter in order to fix it to the chest, the catheter was suddenly snapped and broke.The perivac catheter was exchanged for another and the procedure was completed successfully with no patient complications.

• Brand Name: PERIVAC PERICARDIOCENTESIS KITS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13672467
• Report Number: 2134265-2022-02474
• Device Sequence Number: 5375494
• Product Code: DQX
• UDI-Device Identifier: 08714729333258
• UDI-Public: 08714729333258
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 08/31/2023
• Device Model Number: 86445
• Device Catalogue Number: 86445
• Device Lot Number: 0027937373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male