MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 biopsy forceps was used in a dissection and removal of intra-gastric lap band procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a radial jaw was used to grasp the jagwire.However, the anesthetist noticed the patient hemorrhaging from the mouth when the guidewire was in position and the doctor was threading the mechanical lithotripsy sheath on the wire.The doctor had the gastroscope in the esophagus awaiting for the lithocrush to arrive.The patient was under general anesthetic.The planned procedure was halted; emergency ent (ear, nose, and throat) and gi (gastrointestinal) surgical consultations occurred, emergency bleeding and wound management (mouth/base of tongue) was carried out.The planned procedure was completed following which the patient was admitted to icu (intensive care unit) under sedation.Patient obesity with a large tongue was reported as one of the co-morbidities that possibly lead to the event.Reportedly, in the physician's assessment in part the device malfunction of the jagwire contributed to hemorrhaging from the mouth.The procedure was completed with a different manufacturer's device.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: patient code 1888 captures the reportable event of patient hemorrhaging from mouth.Block h10: visual inspection found the returned device was in good condition and no visual damage was noted.Functional inspection was performed by retroflex test and the jaws opened and closed as intended.The pin gauge, ring gauge and alignment of the jaws were measured to be within specifications.Based on all available information the device did not present any visual damage and it worked as intended.Bleeding is listed as a known potential complication associated with the use of the device.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 biopsy forceps was used in a dissection and removal of intra-gastric lap band procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a radial jaw was used to grasp the jagwire.However, the anesthetist noticed the patient hemorrhaging from the mouth when the guidewire was in position and the doctor was threading the mechanical lithotripsy sheath on the wire.The doctor had the gastroscope in the esophagus awaiting for the lithocrush to arrive.The patient was under general anesthetic.The planned procedure was halted; emergency ent (ear, nose, and throat) and gi (gastrointestinal) surgical consultations occurred, emergency bleeding and wound management (mouth/base of tongue) was carried out.The planned procedure was completed following which the patient was admitted to icu (intensive care unit) under sedation.Patient obesity with a large tongue was reported as one of the co-morbidities that possibly lead to the event.Reportedly, in the physician's assessment in part the device malfunction of the jagwire contributed to hemorrhaging from the mouth.The procedure was completed with a different manufacturer's device.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10889123
• Report Number: 3005099803-2020-05619
• Device Sequence Number: 19640537
• Product Code: FCL
• UDI-Device Identifier: 08714729761877
• UDI-Public: 08714729761877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 10/01/2022
• Device Model Number: M00513323
• Device Catalogue Number: 51420
• Device Lot Number: 0024533964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization