MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR METAL BOLT KIT R; ICP MICROSENSORS (ROHS)

Model Number 626638US

Device Problem No Device Output (1435)

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

Event Type  Injury  

Event Description

A facility reported a microsensor (id 626638) was implanted on (b)(6) 2023.However, it stopped reading on (b)(6) 2023, and showed an error: ¿transducer not detected.¿ the sensor was explanted on (b)(6) 2023.The patient did not show any signs and symptoms and was discharged.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The microsensor (id 626638) was returned for evaluation.Device history record (dhr): the product 626638us for lot: 6745403, (sn: (b)(6), and the lot met specifications when released.Failure analysis - the issue of the complaint has been confirmed: catheter kinked 22cm connector and 5cm from sensor tip, catheter received covered in tape.Icp express an no transducer detected.Internal wires broken at kink on connector end.No testing was possible.The possible root cause of the issue reported by customer could be determined as a mishandling of the catheter.

Event Description

N/a.

• Brand Name: MICROSENSOR METAL BOLT KIT R
• Type of Device: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16733045
• MDR Text Key: 313223408
• Report Number: 3013886523-2023-00108
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K153347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 626638US
• Device Catalogue Number: 626638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1