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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET; CATHETER EMBOLECTOMY
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ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET; CATHETER EMBOLECTOMY Back to Search Results
Catalog Number PT-65509
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During use at an angle not linear, the device needed to be re-sheathed and removed but would not re-sheath.The reported defect was detected during use.There is no patient injury, complication or consequence.The patient condition is reported as "fine".Therapy was not delayed/interrupted.
 
Event Description
During use at an angle not linear, the device needed to be re-sheathed and removed but would not re-sheath.The reported defect was detected during use.There is no patient injury, complication or consequence.The patient condition is reported as "fine".Therapy was not delayed/interrupted.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned 5 fr ptd catheter assembly with its lidstock and a rotator drive unit with its lidstock for evaluation.The ptd device showed evidence of use, the drive unit displayed no evidence of deformities or anomalies.Visual examination of the catheter sheath revealed a tear distal to the catheter hub assembly; this is where the catheter cable separated.Visual examination of the basket assembly revealed no defects or anomalies.The catheter hub assembly also appeared to be fully intact.Microscopic examination revealed that coils of the catheter cable wires were unraveled and stretched where the separation occurred indicating it was stuck or pulled before.The torque cable coil wires in the sheath were broken at the tear.No damage was observed with the basket assembly and the black pebax tip remained secured to the basket.Evidence of use in the form of dried blood was observed on the basket tip.The length of the two separated catheter pieces were measured 4.5625" and 24.375" making an overall length of 28.9375" which is within specification of 28.75-29.25" per product drawing.The length of the black tip measured 0.5625" which is within specification of 0.5156-0.5626" per product drawing.Based on these dimensional values, the ptd catheter broke 24.375" from the distal tip.The catheter body was able to be retracted and advanced in and out of the sheath with minimal resistance.The catheter body spun as expected within the sheath when the catheter hub assembly was rotated by hand.A device history record review was performed on the ptd catheter with no relevant findings.The instructions-for-use (ifu) provided with this product lists warnings to ensure the exposed portion of the catheter remains straight at all times to aid in successful basket deployment.It states that the catheter assembly is not to be advanced forward during activation and not to advance the device beyond the anastomosis.It also warns that potential fatigue failure of the torque cable and fragmentation basket may occur with prolonged activation and a withdrawal rate of 1- cm /second is recommended when sharp radii are encountered.The reported complaint of ptd cable separation was confirmed through visual examination of the returned sample.The catheter was completely separated and the cables were unraveled and stretched indicating it was stuck or pulled before the break.A device history record review did not reveal any manufacturing related issues.Based on the time of discovery and the condition of the catheter cable wires at the break, unintentional user error caused or contributed to this complaint.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
Type of Device
CATHETER EMBOLECTOMY
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9376331
MDR Text Key177609558
Report Number9680794-2019-00471
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,user f
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/31/2020
Device Catalogue NumberPT-65509
Device Lot Number13F18H0911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.; UNKNOWN.
Patient Age48 YR
Patient Weight128
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