MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT; CATHETER, EMBOLECTOMY

Catalog Number PT-65709-WC

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports: the basket at the end did not move and did not enter the catheter.The doctor used a new product.The procedure was completed without any abnormality.

Event Description

The customer reports: the basket at the end did not move and did not enter the catheter.The doctor used a new product.The procedure was completed without any abnormality.

Manufacturer Narrative

Qn#(b)(4).The customer returned multiple components from a ptd kit.No evidence of use was observed on any of the returned components (including the ptd catheter and insertion sheaths), which contradicts the customer report that the defect was observed during use.Visual examination of the ptd basket and sheath did not reveal any damage, defects or anomalies.Microscopic examination of the sheath body did not reveal any dried blood within the sheath which is typical of used ptd catheters.Visual analysis did reveal that the driver hub at the proximal end of the catheter had separated from the rest of the assembly.This caused the cable stop to detach from the assembly.Microscopic examination confirmed the separation and revealed that no scratch marks or any other defects were observed on the cable.The proximal end of the metal tubing outer diameter (the area where the driver hub fits on the assembly) measured.0650", which is consistent with the nominal value of.065" per the metal tubing graphic.The ptd basket was manually retracted back within the sheath with little to no resistance.This indicates that the basket and sheath were functioning as expected.The manufacturing facility was contacted in regards to the separated proximal hub observed.Manufacturing engineering indicated that the hub position on the cable is 100% inspected in-process to ensure the hub was molded to the cable properly.The defect observed with the returned sample (separation of the hub) does not appear to be directly correlated to the customer reported defect of basket retraction issues.A lab inventory long pin was passed through the ptd cable to ensure patency.Little to no resistance was observed as the gage was able to pass completely through the cable.This indicates that no dried biological material is present within the device.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "expose fragmentation basket from outer sheath into deployed position by sliding sidearm from slot no.1 to slot no.2.Activate rotator to break up arterial plug using contrast to guide thrombolysis." the ifu then states, "remove guidewire, if applicable.Place device into compressed position and remove from sheath".The report of that the ptd basket would not retract inside the sheath could not be confirmed through complaint investigation.Functional evaluation of the returned device revealed the basket was able to fully retract and deploy in and out of the sheath as expected.No damage, defects or anomalies were identified with the basket/sheath components.Further analysis did reveal that the driver hub at the proximal end of the cable was separated from the assembly, however, the molding process for the hub is 100% inspected in-process and the defect does not appear to be directly correlated to the customer reported defect of basket retraction issues.The cable met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Additionally, there was no evidence of use observed on the returned device nor the returned insertion sheaths which contradicts the customer report of the defect being identified during use.Based on the functional test and the discrepancy between the customer report (defect during use) and the returned sample (no evidence of use), the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10002518
• MDR Text Key: 189153895
• Report Number: 9680794-2020-00193
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: PT-65709-WC
• Device Lot Number: 13F18J0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1