MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW SYSTEM; STEREOTAXY

Catalog Number XXX-CRW

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the trajectory of the crw system was off.It was reported that during a monteris ablation procedure on (b)(6) 2020, the first trajectory was noted to be off superiorly which was found during the first 3d background scan.The user then performed a new ct to enable a new trajectory.The monteris clinical specialist who supported the case stated that one of the crw balls were not fully seated which threw off the trajectory.A new ct was then taken, and the patient was noted to have a bleed.The procedure was then aborted, and the patient was held for further evaluation.The product was retained by the hospital.Additional information was received stating that the patient was a pediatric patient, gender unknown.It was unknown if there was a surgical delay.Request for additional information has been sent.

Event Description

N/a.

Manufacturer Narrative

Additional information received from the integra sales representative on 12mar2020 indicating that the neuro coordinator at the user facility stated that she has heard of no complaints or issues regarding the crw.Additional information was received on 24mar2020 from the clinical specialist from (b)(6) medical indicating that "i¿m not sure what was reported on the musc end.I put the complaint in as i observed it.The trajectory was off target prior to the ablation.We had to go back to the or to re-plan a trajectory".We realized that the trajectory was off and at the same time that there may have been a bleed.The mri image taken gave us this info.The doctor then told our sales representative that while they were in ct, there was a bleed and they were not going to do another trajectory".

Event Description

N/a.

Manufacturer Narrative

The device was not returned for evaluation.Device history record (dhr) review unable to be completed as the product id number is unknown, and there was no lot number or serial number provided.The reported complaint was unable to be confirmed through failure analysis, as not enough information has been provided.

• Brand Name: CRW SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10279251
• MDR Text Key: 203906395
• Report Number: 3004608878-2020-00147
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CRW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1