MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MULTIBITE; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00510101
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).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 multibite biopsy forceps was used in the esophagus during a biopsy procedure performed on (b)(6) 2019.Reportedly, the patient had a history of dysphagia according to the complainant, during the procedure, the patient's mucosa was noted to be soft and was torn upon insertion of the scope.When the multibite forceps were pushed up against the distal esophagus, they punctured through the esophagus creating a 3-4 mm hole.The perforation was clipped closed and the procedure was completed with a radial jaw 4 standard capacity biopsy forceps.The patient was admitted to the hospital on (b)(6) 2019 due to the perforation.

• Brand Name: MULTIBITE
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9282624
• Report Number: 3005099803-2019-05374
• Device Sequence Number: 19389359
• Product Code: FCL
• UDI-Device Identifier: 08714729164975
• UDI-Public: 08714729164975
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: M00510101
• Device Catalogue Number: 1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• 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: Hospitalization; Required Intervention