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

Catalog Number PT-65709-W

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the ptd basket broke.

Event Description

The customer reports that the ptd basket broke.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.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.

Manufacturer Narrative

(b)(4).The customer returned a 7fr ptd catheter inserted through a non-arrow psi sheath.Signs-of-use in the form of biological material was observed on the ptd basket.After failing functional testing, a lab inventory scalpel was used to cut open a portion of the sheath body.Large amounts of a white, unknown material in combination with dried biological material was observed.Visual analysis of the basket wires revealed that two of the ptd basket wires had disconnected from the proximal connector.These wires were still connected to the distal connector.The other two wires appeared to be intact.The black pebax tip remained attached to the distal basket connector.Microscopic evaluation of the separation points on the broken wires revealed they were jagged, which indicates a tear.In addition to the wires, it was also discovered that the orange lumen had separated at the proximal end of the basket and was protruding from the pebax tip.The separated orange inner lumen measured 47mm in length.Each of the defective basket wires measured approximately 37mm in length, indicating they broke in approximately the same locations.The ptd basket was not able to be retracted back into the sheath as the damage to the wires at the proximal connector prevented this from occurring.The ptd was attached to a lab inventory rotator.The button was pressed, and the basket wires rotated; however, it was very slow.It was later discovered that a large amount of a white, unknown material in combination with dried biological material prevented the rotation.R and d was contacted as part of this complaint investigation.They indicated that neither the torque cable nor the shrink tube undergo 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 review was originally performed based on sales history; however, the lot number on the returned lidstock does not match this potential lot.Therefore, a second dhr was completed to accommodate the lot number on the returned lidstock.No relevant findings were identified.The instructions-for-use (ifu) provided with this product states under general warnings 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 customer report of a separated ptd basket tip was confirmed through complaint investigation of the returned sample.Visual inspection revealed that two of the four basket wires had separated from the proximal connector.Microscopic examination revealed that the points of separation were jagged, which indicates the wires did not separate cleanly.Functional analysis also revealed a build-up of dried biological material in combination with an unknown, white substance inside the sheath.This likely contributed to the damage on the basket wires.A device history record review was performed, and no relevant findings were identified.Based on the observed damage and the customer description, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the ptd basket broke.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10436689
• MDR Text Key: 203838547
• Report Number: 9680794-2020-00334
• 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,Followup
• Report Date: 07/29/2020

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-W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 10/30/2020
• Supplement Dates FDA Received: 09/13/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1