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

Model Number	IPN035902
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "during a thrombectomy procedure the trerotola device being used stopped rotating and was unable to be removed from the patient, it seemed to be snagged in the patients arm.The device was left in the patient and transferred to the er.The basket and drive unit remained with the patient.The unit stopped, it is unclear if it started to slow down prior.Dr.Reported the unit stopped all of a sudden like it snagged." the patient underwent emergency exploration of left upper arm, removal of retained tretola catheter, and repair of cephalic vein.Following surgery, the patient was taken to the recovery room in stable condition and reported to be "doing well without problems".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "potential fatigue failure of the ptd torque cable and fragmentation basket may occur with prolonged activation of ptd device.The cumulative activation time of the ptd device in all radii should be limited to 30-60 seconds.A rapid withdrawal rate of 1-2 cm/second is recommended when sharp radii are encountered (i.E.Radius of loop graft or vessel, radii < 3 cm)." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: "during a thrombectomy procedure the trerotola device being used stopped rotating and was unable to be removed from the patient, it seemed to be snagged in the patients arm.The device was left in the patient and transferred to the er.The basket and drive unit remained with the patient.The unit stopped, it is unclear if it started to slow down prior.Dr.Reported the unit stopped all of a sudden like it snagged." the patient underwent emergency exploration of left upper arm, removal of retained tretola catheter, and repair of cephalic vein.Following surgery, the patient was taken to the recovery room in stable condition and reported to be "doing well without problems".

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
• Common Device Name: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11870658
• Report Number: 9680794-2021-00248
• Device Sequence Number: 3911695
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20M0175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention