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

Catalog Number PT-65709-WC

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "md was performing the procedure according to ifu.Md found that fragmentation basket was kinked and replaced it with its new product".No patient harm reported.

Manufacturer Narrative

(b)(4).The customer returned one ptd catheter and one rotator for analysis.Signs-of-use in the form of biological material was observed on the rotator and the basket wires.Large amounts of biological material were observed at the distal end of the basket wires.Visual analysis revealed that the basket lumen (orange lumen) was kinked within the basket wires.Stress marks were observed on the lumen body, which indicates undue force likely caused or contributed to this event.Upon performing additional testing, it was observed that the free floating distal end of the orange lumen had become dislodged from the distal connection port.No stress marks were observed at the distal tip of the orange lumen, which indicates that no portion of the lumen had separated.The appearance of the damage appears consistent with undue force being applied during use.The orange lumen outer diameter measured.036" which is within the specification limits of.035"-.039" per the basket lumen graphic.The inner diameter of the orange lumen measured.028", which is within the specification limits of.026"-.030" per the basket lumen graphic.Functional testing was performed by attaching the catheter to the ptd rotator.The black power button was switched on and the ptd rotator appeared to rotate as intended.Performed per ifu statement, "depress on/off switch to ensure that fragmentation basket spins freely.Release switch to stop motor." the basket wires were able to be retracted and deployed with little to no difficulty.Performed per ifu statement "unlock and slide side arm from slot no.1 to slot no.2.Lock into place (refer to fig.4).The outer cover catheter will be retracted to expose the basket.This is the deployed position used to treat thrombus in graft/fistula".A manual tug test on the orange lumen revealed that it is secure at the proximal connection point, but had become dislodged from the distal connection point.R and d was consulted and confirmed that the orange lumen is only intended to be connected at the proximal end of the basket wire.The distal end should float freely inside the black flex tip to allow the basket to expand and contract as needed to conform to the vessel.It also allows the basket to be compressed inside the ptd sheath.This confirms that this is not a manufacturing or design related issue.Manufacturing was also consulted who confirmed that the basket wires/orange lumen are 100% inspected for defects.They also test to ensure that the orange lumen is secure at the proximal connection point and loose at the distal connection point prior to product release.The biological material was removed from the distal end of the basket wire.The orange lumen was reinserted through the distal tip with little to no difficulty.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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".The customer report of a damaged ptd tip/lumen was confirmed based on visual investigation of the received sample.The orange lumen was kinked around the middle of the extrusion.Further analysis revealed that the distal end of the extrusion had become dislodged from the distal basket wire connection point.R and d confirmed that the distal end is meant to float free within the black flex tip as part of the product design.The sample met all relevant dimensional and functional requirements and no there was no evidence to suggest a manufacturing related issue.Based on the customer report, the sample received, and the amount of biomaterial on the basket wires, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "md was performing the procedure according to ifu.Md found that fragmentation basket was kinked and replaced it with its new product".No patient harm reported.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12030364
• MDR Text Key: 258662955
• Report Number: 9680794-2021-00323
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: PT-65709-WC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/20/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1