MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY

Model Number	IPN035902
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the basket broke apart inside of the patient while the physician was using the device.The physician was able to retrieve any pieces with a snare.No patient injury or complication was reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: the basket broke apart inside of the patient while the physician was using the device.The physician was able to retrieve any pieces with a snare.No patient injury or complication was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 5fr ptd catheter and lidstock.Visual examination revealed a small piece of metal tangled in the ptd basket.The metal appeared to be a portion of a mesh stent.The ptd basket wires appeared fully welded and secured.The pebax tip was also fully formed and undamaged.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs, "side side arm on hemostasis hub forward so outer catheter covers and compresses fragmentation basket.The plastic, flexible tip of the basket should be exposed at this point.Turn and lock side arm into slot no.1 to prevent outer sheath from moving." the returned ptd basket was unable to retract or advance from the returned sheath due to the stent tangled in the basket.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "the ptd device is not for use in stents".The customer report of a broken ptd basket was not confirmed by complaint investigation of the returned sample.The basket wires were fully welded and secured; however, a mesh stent was observed tangled in the ptd basket.The ifu provided with this kit warns the user, "the ptd device is not for use in stents." therefore, intentional user error caused or contributed to this event.An in-service request has been initiated to further educate the customer on this product's intended use.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
• Common Device Name: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11400313
• Report Number: 9680794-2021-00075
• Device Sequence Number: 1165024
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 09/30/2022
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20K0630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention