MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE PROKNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation during a retrospective series data collection that an orise proknife was used in the distal esophagus/gastroesophageal (ge) junction during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.An i knife and nanoknife 165 (non-bsc devices) were also used in the procedure.An esophageal hemorrhage occurred 11-12 days post-op from a vessel under the procedure site.The physician deemed the event to be not related to the device and probably related to the procedure.The patient was hospitalized and underwent an endoscopic reintervention for the esophageal hemorrhage.The patient was discharged three days later on (b)(6) 2021.

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: corrections: h6 (impact code).

Event Description

It was reported to boston scientific corporation during a retrospective series data collection that an orise proknife was used in the distal esophagus/gastroesophageal (ge) junction during an endoscopic submucosal dissection (esd) procedure performed on (b)(6), 2021.An i knife and nanoknife 165 (non-bsc devices) were also used in the procedure.An esophageal hemorrhage occurred 11-12 days post-op from a vessel under the procedure site.The physician deemed the event to be not related to the device and probably related to the procedure.The patient was hospitalized and underwent an endoscopic reintervention for the esophageal hemorrhage.The patient was discharged three days later on (b)(6), 2021.

• Brand Name: ORISE PROKNIFE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14088659
• MDR Text Key: 289359311
• Report Number: 3005099803-2022-01613
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White