MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SEMI-FINISHED KIT: 7FR PTD OTW CATH 65CM; CATHETER, EMBOLECTOMY

Catalog Number PT-65709-C

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "basket catheter got 'boogered up' in 7fr sheath.The basket doesn't go through the sheath and had to get new ones." it was reported the catheter approximately 10-20cm from the basket head buckled in the sheath.The device was retrieved.The basket catheter was replaced and procedure proceeded as normal.No patient harm reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "basket catheter got 'boogered up' in 7fr sheath.The basket doesn't go through the sheath and had to get new ones." it was reported the catheter approximately 10-20cm from the basket head buckled in the sheath.The device was retrieved.The basket catheter was replaced and procedure proceeded as normal.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one ptd catheter assembly and one lidstock for analysis.Signs-of-use in the form of biological material was observed inside the sheath.A blue, non-arrow guide wire was returned inserted through the torque cable.The basket was returned completely deployed out of the ptd sheath.After failing functional testing, it was determined that something within the sheath was likely causing the heavy resistance, which subsequently prevented the basket wires from retracting/deploying.A lab inventory scalpel was used to cut into several locations along the sheath body.Large amounts of dried biological material were observed inside the sheath.The sheath body was also kinked towards the proximal end.This likely contributed to the resistance.While performing functional testing, the torque cable became partially unraveled.This also caused the shrink tube to retract, which exposed a portion of the torque cable.The outer diameter of the exposed torque cable measured 1.35mm, which is within the specification limits of 1.296mm-1.372mm per the torque cable graphic.To measure the inner diameter of the sheath, the torque cable was severed.The inner diameter of the sheath measured.079", which is within the specification limits of.077"-.080" per the sheath extrusion graphic.The sheath outer diameter.095", which is within the specification limits of.094"-.096" per the sheath extrusion graphic.Upon attempting to retract the ptd cable into the sheath, major resistance was encountered.Excessive force applied to the cable resulted in the proximal end of the cable to unravel.This also caused the metal tubing at the proximal end to become separated from its fixed position.However, this did not impact the root cause of this investigation.The ptd catheter could not be connected to a lab inventory ptd rotator due to the damage on the torque cable.A device history record review was performed based on the lot# on the returned lidstock.No relevant findings were identified.The ifu provided with the kit informs the user, "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".The ifu also stares, "flush catheter lumen with heparinized saline and manually remove any accumulated fibrin from fragmentation basket.Inject small amount of contrast to ensure that adequate thrombolysis of venous limb has been accomplished.Avoid over-injection of contrast to minimize the risk of arterial embolization".The customer report that the ptd basket could not be retracted back into the sheath was confirmed through functional evaluation of the returned sample.The ptd catheter was returned with the ptd basket completely deployed; however, it could not be retracted back into the sheath.The sheath body was cut open and significant amounts of a dried biological material was observed inside the sheath.The sheath met all relevant dimensional requirement, and a device history record review was performed with no relevant findings.Based on the condition of the returned sample and the time of discovery, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SEMI-FINISHED KIT: 7FR PTD OTW CATH 65CM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10655001
• MDR Text Key: 210640317
• Report Number: 9680794-2020-00435
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: No Information
• Device Catalogue Number: PT-65709-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.