MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Retraction Problem (1536); Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos, images and videos were provided for review.The investigation of the reported event is currently underway.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during a recanalization procedure, the tip of catheter was allegedly out of shape after first round of use.It was further reported that device cannot remove from the sheath.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing-related cause for this event.Investigation summary: the sample was returned for evaluation.A catheter was physically investigated.The catheter was sent with guidewire and introducer sheath connected and stuck together.The tube kink at 22 cm distance from the tip of the catheter was noted.The tip of the tube was melted on the helix.The coiled tip of the guidewire was missing, and guidewire was delaminated at the place of the tube kink (22 cm).The inside of the catheter and helix were heavily blocked with the coagulated material.It was not possible to run the catheter due to blockage.Therefor, the investigation is confirmed for the reported issues.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during a recanalization procedure, the tip of catheter was allegedly out of shape after first round of use.It was further reported that device cannot remove from the sheath.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during a recanalization procedure, the tip of catheter was allegedly out of shape after first round of use.It was further reported that device cannot remove from the sheath.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos, images and videos were provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17285606
• MDR Text Key: 319108133
• Report Number: 3008439199-2023-00116
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2023

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 Model Number: VERSION 1.0
• Device Catalogue Number: 80201
• Device Lot Number: 221844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/07/2023; 09/14/2023
• Supplement Dates FDA Received: 07/30/2023; 09/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1