MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7; CATHETER, EMBOLECTOMY

Model Number	IPN036254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the device broke apart while being removed.A piece came off into the patient, but it was able to be removed while removing the wire.No pieces were retained in the patient.No patient injury or harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: the device broke apart while being removed.A piece came off into the patient, but it was able to be removed while removing the wire.No pieces were retained in the patient.No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 7fr ptd catheter and lidstock for evaluation.Visual examination revealed the orange basket lumen was pulled/separated from the basket assembly.Microscopic examination of the proximal end of the separation revealed the imprint form the basket wires; however, no evidence of shearing/tearing was observed.This indicates that the orange lumen was not properly assembled to the basket wires.The orange lumen measured 1.870", which is within the specification limits of 1.860"-1.890" per the basket lumen graphic.The orange lumen outer diameter measured.0355", which is within the specification limits of.0350"-.0390" per the basket lumen graphic.The orange lumen inner diameter measured.027", which is within the specification limits of.026"-.030" per the basket lumen graphic.The ptd basket was able to advance and retract in the ptd sheath.The ptd catheter assembly was attached to a lab inventory rotator.When the button was pressed, the assembly functioned as expected.Performed per ifu statement, "unlock and slide side arm from slot no.1 to slot no.2.Lock into place.The outer cover catheter will be retracted to expose the basket.This is the deployed position used to treat thrombus in graft/fistula.Depress on/off switch to ensure that fragmentation basket spins freely.Release switch to stop motor.If any part of system fails to work properly , replace component and retest".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "potential fatigue failure of ptd torque cable and fragmentation basket may occur with prolonged activation of ptd device.When using the ptd within the apex of a forearm loop graft, limit operation to 3 minutes or less to reduce the potential for basket failure.A rapid withdrawal rate of 1-2 cm/second is recommended when sharp radii are encountered (i.E., radius of loop graft, radii < 3 cm)".The customer report of a separated inner lumen was confirmed by complaint investigation of the returned sample.The orange lumen appeared to be completely dislodged from the basket wire assembly and was deformed, indicating that the lumen was not properly secured within the device.The ptd assembly passed all relevant functional testing.Based on the sample received, manufacturing (assembly) caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11736834
• Report Number: 9680794-2021-00170
• Device Sequence Number: 11680734
• Product Code: DXE
• UDI-Device Identifier: 10801902121315
• UDI-Public: 10801902121315
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/07/2021

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: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN036254
• Device Catalogue Number: PT-65709-W
• Device Lot Number: 13F20G0361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1