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

Model Number	M00515181
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/03/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2020.According to the complainant, the patient was suspected to have a malignant tumor in the lung.During the procedure, after 12 biopsies were taken, the patient began to bleed.Ice water lavage was used to slow the bleeding and the scope was removed.The patient then began to bleed from the nose and mouth.The physician was unable to re-intubate the patient.The patient was unable to be resuscitated.The patient expired at approximately 12:30 on (b)(6) 2020.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2020.According to the complainant, the patient was suspected to have a malignant tumor in the lung.During the procedure, after 12 biopsies were taken, the patient began to bleed.Ice water lavage was used to slow the bleeding and the scope was removed.The patient then began to bleed from the nose and mouth.The physician was unable to re-intubate the patient.The patient was unable to be resuscitated.The patient expired at approximately 12:30 on (b)(6) 2020.No further information has been obtained despite good faith efforts.Additional information received february 07, 2020: the biopsies were taken in the right upper lobe.According to the physician, the patient was expected to bleed due to the nature of the lesion, a malignancy.Additionally, the physician confirmed that there were no issues with the forceps.
Additional Manufacturer Narrative
Block h2: block b5 have been updated based on additional information received on february 07, 2020.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h2: correction block b5: the original event description for supplemental-001 that was sent on march 03, 2020 was edited in error.The event description has been corrected to the original event.
Additional Manufacturer Narrative
Block h2: block b5 have been updated based on additional information received on february 07, 2020.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a bronchoscopy with biopsy procedure performed on (b)(6) 10, 2020.According to the complainant, during the procedure, a biopsy was performed for a suspected malignant tumor.After the first biopsy, the site began to bleed.Ice water flush was used to slow the bleeding.A second biopsy was then taken and more bleeding occurred.Ice water flushes were used again.A rapid response team was called and the patient was stabilized.The patient was then brought to the post anesthesia care unit and was released from the hospital on the same day.There were no reported issues with the device.Additional information received february 07, 2020: the biopsies were taken in the right upper lobe.According to the physician, the patient was expected to bleed due to the nature of the lesion, a malignancy.Additionally, the physician confirmed that there were no issues with the forceps.

• 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: 9679665
• Report Number: 3005099803-2020-00202
• Device Sequence Number: 19625284
• Product Code: FCL
• UDI-Device Identifier: 08714729792864
• UDI-Public: 08714729792864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: M00515181
• Device Catalogue Number: 1518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/07/2020; 03/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/03/2020; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR