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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 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "md opened a new kit and was performing the procedure according to ifu.But after inserting it, md checked it was not working.Md found that the guide wire was broken and the catheter was kinked.So md opened used new product and finished the procedure without abnormality." no patient harm reported.The patient's condition is reported as fine.
 
Event Description
The complaint is reported as: "md opened a new kit and was performing the procedure according to ifu.But after inserting it, md checked it was not working.Md found that the guide wire was broken and the catheter was kinked.So md opened used new product and finished the procedure without abnormality." no patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one ptd catheter assembly and ptd rotator for evaluation.Signs-of-use in the form of biological material were observed.Visual examination revealed the sheath body was kinked and the ptd torque cable had separated adjacent to the distal weld of the metal tubing.The coils of the torque cable were twisted and deformed at the point of separation.When fully assembled, the point of separation on the cable was coincident with the kink on the sheath.This damage is consistent with undue tension being applied to the ptd catheter body.The ptd catheter separation point was 635mm from the distal tip.The sheath body was kinked 2.25" from the juncture hub.The ptd sheath total body length from the proximal end of the hub to the distal tip measured 64.9cm, which is within the specification limits of 64.7cm-65cm.The outer diameter of the ptd sheath measured.0951", which is within the specification limits of.094"-.096" per the sheath extrusion graphic.The sheath inner diameter at the distal tip measured.079", which is within the specification limits of.077"-.080" per the sheath ext assembly graphic.Functional inspection could not be performed due to the damage on the returned ptd catheter.A device history record review was performed, and 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 (i.E., radius of loop graft, radii < 3 cm)"."warning: do not advance ptd catheter forward during activation." the report of a separated torque cable was confirmed through complaint investigation.Visual analysis revealed the sheath body was kinked and the ptd torque cable had separated directly adjacent to the distal end of the metal tubing.The coils of the torque cable were twisted and deformed at the point of separation.When fully assembled, the point of separation on the cable was coincident with the kink on the sheath.A device history record review was performed, and no relevant findings were identified.R & d was consulted as part of this complaint investigation.They concluded that the damage observed is most consistent with unintentional user-error (excessive stress).Based on the condition of the sample received (evidence of use), the defect observed and the comments from r & d, 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 Key11757744
MDR Text Key249667588
Report Number9680794-2021-00184
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 04/12/2021
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 Expiration Date08/31/2021
Device Catalogue NumberPT-65709-WC
Device Lot Number13F19J0199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Initial Date Manufacturer Received 04/12/2021
Initial Date FDA Received04/30/2021
Supplement Dates Manufacturer Received06/01/2021
Supplement Dates FDA Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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