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.

Manufacturer Narrative

(b)(4).The customer returned one ptd catheter, one rotator, and two lidstocks (one for rotator and one for catheter) for analysis.Signs-of-use in the form of biological material was observed inside the sheath.A blue, non-arrow guide wire was inserted through the sheath and was stuck.The basket wire was completely retracted into the sheath.The sheath was returned with the basket wire completely retracted into the 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.A white, powdery substance was observed inside a portion of the sheath.This substance had dried to the cable body.In addition to the heavy resistance, the sample was also returned with the orange lumen separated and protruding from the pebax tip.The sheath body was also kinked towards the proximal hub.Despite these additional defects, the customer was unable to provide additional information in their initial description nor the follow-up.While performing functional testing, the shrink tubing around the torque cable had slightly peeled back exposing a portion of the cable.The outer diameter of this exposed section measured 1.37mm, 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 sheath inner diameter measured.080", which is within the specification limits of.077"-.080" per the sheath extrusion graphic.The sheath outer diameter measured.095", which is within the specification limits of.094"-.096" per the sheath extrusion graphic.An attempt to deploy and retract the basket wire was performed.Major resistance was observed, which prevented the torque cable from moving.The sheath could not be attached to the returned rotator as the heavy resistance prevented the basket wires from deploying.R and d was contacted as part of this complaint investigation.They indicated that neither the torque cable nor the shrink tube undergoes any type of coating or any other process that would have introduced this unknown white substance.Therefore, it can be assumed that this was introduced by the customer.A device history record review was performed based on the lot# from the returned lidstock, and 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 states, "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 basket completely retracted and could not be further deployed.The sheath body was cut open and significant amounts of a dried, white powdery substance was observed.This in combination with dried biological material caused the heavy resistance.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.

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.

• 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: 10654771
• MDR Text Key: 210624053
• Report Number: 9680794-2020-00434
• 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.