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

Model Number	86445
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a occlusion occurred.A perivac pericardiocentesis kit was selected for a pericardiocentesis procedure.During the procedure it was noticed that the catheter was occluded the "distal tip is not well sucked because the hole is replaced".The procedure was completed with no patients complications being reported.
Additional Manufacturer Narrative
There is dried body fluid on the pigtail drainage catheter.A thin dry clear membrane along with dried blood is present inside the pigtail drainage catheter distal end.The membrane is fragile and appears to be an organic material spanning the entire opening and is surrounded by a ring of dried blood/ body fluid on the interior sides of the catheter.All the drainage sideholes of the catheter are open and no foreign material is visible.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that a occlusion occurred.A perivac pericardiocentesis kit was selected for a pericardiocentesis procedure.During the procedure it was noticed that the catheter was occluded the "distal tip is not well sucked because the hole is replaced".The procedure was completed with no patients complications being reported.

• Brand Name: PERIVAC PERICARDIOCENTESIS KITS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8842658
• Report Number: 2134265-2019-08977
• Device Sequence Number: 16497084
• Product Code: DQX
• UDI-Device Identifier: 08714729333234
• UDI-Public: 08714729333234
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 02/19/2021
• Device Model Number: 86445
• Device Catalogue Number: 86445
• Device Lot Number: 0023375852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1
• Patient Age: 75 YR