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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7; CATHETER, EMBOLECTOMY
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ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7; CATHETER, EMBOLECTOMY Back to Search Results
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 the ptd rotator was inoperative because the catheter body was slightly kinked towards the proximal end." no patient injury or harm.The condition of the patient is reported as "fine".
 
Event Description
The complaint is reported as: "md was performing the procedure according to ifu.Md found that the ptd rotator was inoperative because the catheter body was slightly kinked towards the proximal end." no patient injury or harm.The condition of the patient is reported as "fine".
 
Manufacturer Narrative
(b)(4).The customer returned one 7fr ptd catheter and rotator for evaluation.Signs of use in the form of biological material were present on the catheter and rotator.Visual inspection of the catheter revealed one distinct kink in the orange basket lumen.The catheter body also appeared slightly kinked near the proximal end and the sheath appeared twisted near the juncture hub.The total length of the catheter sheath measured 64.8 cm which is within specifications of 64.7-65.0 cm per sheath extension graphic.The outer diameter of the basket lumen measured 0.03830" which is within specifications of 0.035-0.039" per basket lumen graphic.The returned ptd basket was able to advance and retract from the ptd catheter with minimal resistance.Since the returned rotator did not have power, a lab inventory rotator was used.The returned ptd catheter was connected to the lab inventory ptd rotator and the button was depressed for 10 seconds per ifu t-65609-132a rev.01 which states, "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." the catheter rotated as expected.A manual tug test indicated that the lumen was secure within both sides of the basket.The lumen should be free at the distal end in the catheter tip.Additional force was used to remove the lumen from the catheter tip and it was noted that dried biological material on the lumen had secured it to the inner wall of the catheter tip.Manufacturing was previously consulted and 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 this 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.The sample met all relevant dimensional and functional requirements and no there was no evidence to suggest a manufacturing related issue.A device history record review was performed based on a potential lot number from sales history, and no relevant findings were identified.Based on the customer report, the sample received, and the biological material on the lumen, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12159006
MDR Text Key261271379
Report Number9680794-2021-00335
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
PMA/PMN Number
K011056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/21/2021
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 NumberPT-65709-WC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Initial Date Manufacturer Received 06/21/2021
Initial Date FDA Received07/13/2021
Supplement Dates Manufacturer Received07/30/2021
Supplement Dates FDA Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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