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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, 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) 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.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h2: block b5 have been updated based on additional information received on (b)(6), 2020.Block h10: the device has been received for analysis.Upon completion of the failure analysis of the complaint device, 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), 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 on (b)(6), 2020*** 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: visual inspection of the returned device found the clevis was bent.No other visual damage was noted.A functional inspection was performed and found the device failed the retroflex test due to the bent clevis that caused the jaws to not open straight but move to the side when opened.Dimensional inspection was performed and found the device passed the pin gage test; however, the device failed the ring gage test due to the coil condition that increased the specifications of the device diameter.Based on all available information, it is most likely that clevis bent could have been caused by the protection cap being removed at an angle during preparation or by manipulation during procedure.Therefore, the most probable cause for this failure is adverse event related to procedure.As per the directions for use (dfu), hemorrhage is an adverse event that could happen during procedure as a consequence of device usage and nature of the lesion.The dfu cited "adverse events complications associated with the use of the single-use biopsy forceps may include bleeding".Additionally, the dfu warns "these single use biopsy forceps should only be used to biopsy tissue where possible hemorrhage will not present a danger for patients".Therefore, the most probable cause is known inherent risk of device since the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and there is no evidence that the device was not used in accordance with the labeling/dfu.
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) 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 on february 07, 2020.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: 9679710
• Report Number: 3005099803-2020-00203
• Device Sequence Number: 14173599
• 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): 04/29/2020

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: 10/14/2022
• Device Model Number: M00515181
• Device Catalogue Number: 1518
• Device Lot Number: 0024603584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/07/2020; 04/02/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/03/2020; 04/29/2020
• 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: Required Intervention
• Patient Age: 87 YR