MAUDE Adverse Event Report: NINEPOINT MEDICAL, INC. NVISIONVLE MARKING PROBE

Model Number	95301-M-20
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
An nvisionvle marking probe (20mm) was placed through the endoscope into the stomach.During the procedure the balloon was not inflating as quickly as expected, therefore a decision was made to use a new marking probe.The procedure was aborted, and the remaining air was suctioned to deflate the balloon, however the physician prematurely pulled the marking probe back through the endoscope and the balloon detached from the marking probe and lodged in the endoscope channel.The physician decided to advance the scope into the stomach and push the balloon from the endoscope channel using biopsy forceps into the stomach.A snare was used to obtain the balloon from the stomach.The patient was un-harmed, and case completed using the new marking probe.

• Brand Name: NVISIONVLE MARKING PROBE
• Common Device Name: NVISIONVLE MARKING PROBE
• Manufacturer (Section D): NINEPOINT MEDICAL, INC.; 12 oak park drive; bedford MA 01730
• MDR Report Key: 6329110
• Report Number: 3008805841-2017-00001
• Device Sequence Number: 1610145
• Product Code: NQQ
• UDI-Device Identifier: 00859591006072
• UDI-Public: (01)00859591006072(17)170930(10)004904
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K153479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 95301-M-20
• Device Catalogue Number: 95301-M-20
• Device Lot Number: 004904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE (NO MFGR SPECIFIED)
• Outcome Attributed to Adverse Event: Required Intervention