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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY
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ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY Back to Search Results
Catalog Number PT-65509
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/18/2021
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The tip of the basket broke off and lodged in the patient's vessel.There was no attempt to remove the broken piece.The physician placed a stent to hold it in place.It was reported the declotting of the patient's dialysis access was successful and the patient was able to get a treatment the next day.No patient complication reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one 5fr ptd catheter for evaluation.Signs of use in the form of biological material was observed on the catheter.Visual examination revealed the pebax tip was separated from the ptd basket.Microscopic examination confirmed that the black pebax tip broke near the base of the distal basket.The tip material appeared folded and uneven, indicating a stress related tear.The separated pebax tip was not returned.All the basket wires were intact and secured within the basket connectors.The total length of the pebax tip measured to be 0.157" which indicates at least 0.358" were separated and not returned per product drawing.The sample was functionally tested in accordance with the instructions-for-use, "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." the ptd basket was able to advance and retract from the sheath with minimal resistance.The ptd catheter was placed into a lab inventory rotator to functionally test, and it was able to rotate.No functional issues were found.The instructions for use (ifu) provided with the kit warns the user, "the ptd device is not for use in stents." it also instructs the user, "if the flexible tip "folds over" itself when it encounters the sheath valve, insert the folded-over tip through the valve and pull back slightly to allow tip to unfold in open cavity of the hub.At this point, the device can be fed through the sheath into the graft." the ifu warns, "keep exposed portion of ptd catheter straight at all times to aid in successful basket deployment.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).Do not advance ptd catheter forward during activation." the customer report of a separated ptd basket tip was confirmed by complaint investigation of the returned sample.A portion of the black pebax tip was separated and not returned.The sample passed all relevant functional testing.Further investigation of this issue will be conducted under a capa.The capa root cause was determined to be manufacturing - molding.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The tip of the basket broke off and lodged in the patient's vessel.There was no attempt to remove the broken piece.The physician placed a stent to hold it in place.It was reported the declotting of the patient's dialysis access was successful and the patient was able to get a treatment the next day.No patient complication reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
Type of Device
CATHETER EMBOLECTOMY
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11417238
MDR Text Key239557276
Report Number9680794-2021-00085
Device Sequence Number1
Product Code DXE
UDI-Device Identifier10801902013153
UDI-Public10801902013153
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,health
Type of Report Initial,Followup
Report Date 02/18/2021
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
Device Operator Health Professional
Device Catalogue NumberPT-65509
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Initial Date Manufacturer Received 02/18/2021
Initial Date FDA Received03/04/2021
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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