MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MRINNERVU ENDORECTAL PROSTATE COIL BPX 15; COIL, DISPOSABLE ENDORECTAL BPX 15

Model Number	60727471
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Perforation (2001); Bowel Perforation (2668); Patient Problem/Medical Problem (2688)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject bpx 15 endorectal coil was discarded immediately after removal from the patient and was not available for investigation.There is insufficient evidence of a device malfunction.A 12 month review of complaint history determined the complaint rate to be (b)(4) complaints per million (cpm).
Event or Problem Description
The site reported the following: a (b)(6) male patient with elevated psa levels was undergoing an mri of the prostate.During pre-screening the patient denied any history of rectal problems or trauma.The patient was placed under sedation by anesthesia staff and a bpx 15 endorectal coil was inserted by a prostate clinic nurse into the patient's rectum without any difficulty noted.The site reported that the insertion was done following the instructions for use and that 70 ml of air was used to inflate the balloon.After the mri was completed the air was removed from the balloon with a syringe and the endorectal coil was removed from the patient without difficulty.The nurse removing the endorectal coil noted there was blood on the tip of the endorectal coil.She noticed nothing else unusual with the tip of the endorectal coil.The physician was informed, images were reviewed and a possible rectal tear was identified.During image review it was also noted that the patient had a very unusual significant turn in his rectal anatomy.The patient was taken to the emergency department where he had x-rays performing which revealed free air and a 5 cm rectal tear.The patient then began to complain of abdominal pain.He was taken to the operating room where a diverting colostomy was performed.

• Brand Name: MRINNERVU ENDORECTAL PROSTATE COIL BPX 15
• Common Device Name: COIL, DISPOSABLE ENDORECTAL BPX 15
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 7723567
• Report Number: 2520313-2018-00052
• Device Sequence Number: 1076352
• Product Code: LNH
• UDI-Device Identifier: 00616258009193
• UDI-Public: (01)00616258009193
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K901888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60727471
• Device Catalogue Number: BPX 15
• Device Lot Number: HC009TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/26/2018
• 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
• Patient Age: 63 YR