MAUDE Adverse Event Report: NINEPOINT MEDICAL, INC. NVISIONVLE LOW-PROFILE OPTICAL PROBE

Model Number	95501-LP
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of becoming aware of additional information that was learned through mdr report#3008805841-2018-00003 a review of similar complaints was undertaken.One was identified requiring reassessment of the prior mdr determination, resulting in this report.The nvisionvle® low-profile optical probe was returned to ninepoint medical for evaluation.Device was intact with the exception of the soft tip which had detached during the procedure.The sheath imaging window did not appear to have been stressed in tension.The device history record was reviewed for the returned nvisionvle® low-profile optical probe and no anomalies were identified that could have contributed to this event.Investigation is on-going.Related warnings and precautions in the instructions for use include: 1.To prevent failures in the nvisionvle low-profile optical probe, do not kink or sharply bend it at any time.2.Extreme endoscope manipulations may result in breakage of the optical probe.3.Do not use the nvisionvle low-profile optical probe if the inner package is open or damaged.4.Do not use the nvisionvle low-profile optical probe if the device appears to be damaged.5.The nvisionvle low-profile optical probe is supplied sterile and is designed for single-patient use only.6.Do not reuse or re-sterilize the nvisionvle low-profile optical probe.7.This device should not be used in any anatomy where the labeled diameter would be inappropriate.
Event or Problem Description
The physician selected a nvisionvle® low-profile optical probe for the oct imaging evaluation.The optical probe was placed inside the common bile duct and imaging was performed successfully.It was reported that the soft tip of the optical probe had become detached inside the endoscope during removal.The physician removed the scope from the patient and removed the optical probe soft tip from the scope.No medical intervention was necessary.The patient was not harmed.

• Brand Name: NVISIONVLE LOW-PROFILE OPTICAL PROBE
• Common Device Name: NVISIONVLE LOW-PROFILE OPTICAL PROBE
• Manufacturer (Section D): NINEPOINT MEDICAL, INC.; 12 oak park drive; bedford MA 01730
• MDR Report Key: 7430716
• Report Number: 3008805841-2018-00004
• Device Sequence Number: 16657364
• Product Code: NQQ
• UDI-Device Identifier: 00859591006188
• UDI-Public: (01)00859591006188(17)180731(10)005251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: 95501-LP
• Device Catalogue Number: 95501-LP
• Device Lot Number: 5251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008805841-04/11/18-001R
• Patient Sequence Number: 1