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	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "using trerotola device on an avf (arteriovenous fistula), we were working on the outflow, took the device out to get the clot off and when we took our image we noticed a perforation.Examined the device and the tip of the catheter was missing.We used a stent to cover up the perforation." it was reported the user had taken the device out to clean it and noticed the tip was off.A picture was taken using digital subtraction angiography and revealed a perforation.A stent was placed over the tip and perforation.The patient was reported to be well and did not have any additional complications.
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided three photos for evaluation.The photos displayed the presumed pebax tip separated inside of a patient.A stent also appeared to be present, which confirms the customer report.The customer also returned one 5fr ptd catheter for evaluation.Visual examination revealed the pebax tip was fully separated from the ptd basket and not returned for evaluation.Microscopic examination confirmed the basket wires were fully welded.The returned ptd basket was able to be retracted and advanced from the ptd catheter.The returned ptd catheter was assembled with a lab inventory rotator.When the rotator button was depressed, the ptd catheter performed as expected.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns 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 ptd tip was confirmed by complaint investigation of the returned sample.The ptd pebax tip was completely separated from the basket and was not returned for evaluation.A device history record review was performed with no relevant findings.A capa has previously been initiated to further investigate this issue.The root cause has been determined to be a manufacturing (molding) issue.Corrective actions have not yet been implemented.
Event or Problem Description
Customer reported "using trerotola device on an avf (arteriovenous fistula), we were working on the outflow, took the device out to get the clot off and when we took our image we noticed a perforation.Examined the device and the tip of the catheter was missing.We used a stent to cover up the perforation." it was reported the user had taken the device out to clean it and noticed the tip was off.A picture was taken using digital subtraction angiography and revealed a perforation.A stent was placed over the tip and perforation.The patient was reported to be well and did not have any additional complications.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
• Common Device Name: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11366862
• Report Number: 9680794-2021-00084
• Device Sequence Number: 934223
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/08/2021

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: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20J0771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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