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

Catalog Number PT-65509

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the basket became entangled with the stent during use.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports that the basket became entangled with the stent during use.

Manufacturer Narrative

(b)(4).The customer returned a 5fr ptd catheter attached to a syringe and lidstock for evaluation.The catheter was returned with the basket fully advanced out the sheath.The ptd catheter was visually inspected.None of the basket wires were broken, and the full tip was present.No defects or anomalies were observed on the ptd catheter other than a stent was observed entangled around the basket.The tip of the basket measured.55" which is within specification of.5156-.5626" per product drawing.The overall length of the basket measured 2.9cm which is close to the nominal value of 3cm per product drawing.The ptd basket was able to be retracted back into the sheath as expected.The ptd catheter was attached to an inventory rotator and the basket rotated as expected when the rotator was turned on.A device history record review was performed on the ptd device and no relevant findings were identified.The ifu provided with this kit warns the user "the ptd device is not for use in stents." the customer complaint of the ptd catheter entangled with a stent was confirmed through this investigation.Visual inspection revealed the stent was caught within the basket of the catheter.However, according to the ifu provided with this kit, the ptd devices are not to be used in stents.Therefore, the root cause of this investigation is deemed use error.An in-service was requested to inform the customer not to use the ptd catheter inside stents.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the basket became entangled with the stent during use.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET:
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9185172
• MDR Text Key: 177963298
• Report Number: 9680794-2019-00386
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F19D0494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1