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

Catalog Number PT-65709-WC

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Lot# unknown.Potential lot#: 13f18f0325.

Event Description

During the procedure, tip of the catheter was cut off.Md removed the tip safely and finished the procedure with new product.It was reported that no intervention was required.

Manufacturer Narrative

Qn#(b)(4).The customer returned a 7fr ptd catheter for analysis.Signs-of-use in the form of biological material was observed inside the sheath extrusion.Visual examination revealed that the distal end of the black pebax tip was separated and not returned.Microscopic examination confirmed that the black pebax tip broke near the base of the distal basket.The tip material appeared jagged and uneven, indicating a stress related tear.All the basket wires were intact and secured within the basket connectors.The pebax tip that still adhered to the basket measured to be.07874", which indicates that at least.51126" of the tip was separated and not returned based on specifications.59"-.61" per the product graphic.The ptd basket was able to advance and retract from the sheath with minimal resistance.The ptd catheter was placed into a lab inventory rotator to functionally test, and it was able to rotate.No functional issues were found.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user that the ptd device is not for use in stents.It provides instructions in the event the black flexible basket tip "folds over" itself and while in use, states that the exposed portion of the catheter is to be kept straight at all times to aid in successful basket deployment.It warns that the rotating basket is to be withdrawn in the deployed position prior to reaching the sheath at a recommended rate of 1-2cm/second when sharp radii is encountered and that the catheter is not to be advanced forward during activation.It also warns that potential fatigue failure of the ptd cable and fragmentation basket may occur with prolonged activation of the ptd device.The ifu also provides various warnings and precautions for the user to reevaluate treatment or to consider alternative treatments if there is a presence of venous outflow stenosis greater than 10cm long, untreatable conditions or large pseudo aneurysm.The report that the ptd tip was broken during use was confirmed through examination of the returned sample.Microscopic examination revealed that the distal end of the black pebax tip was broken off.The sample met all relevant functional requirements, and a device history record review was performed based on sales history with no relevant findings.The tip material appeared jagged and uneven, indicating a stress related breakage.A capa has previously been initiated due to an increase ptd tip separations.The capa implementation date was 17th december 2018, which is after the manufacturing date of 17th may 2018.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

During the procedure, tip of the catheter was cut off.Md removed the tip safely and finished the procedure with new product.It was reported that no intervention was required.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10178613
• MDR Text Key: 196060318
• Report Number: 9680794-2020-00287
• 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: 06/12/2020

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 Catalogue Number: PT-65709-WC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1