MAUDE Adverse Event Report: COLOPLAST A/S MANUFACTURING ORCHESTRA HYDROPHILIC GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	AEAD351002
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to available information, though not verified, this patient experienced symptoms associated with pyelonephritis approximately 24 hours after the installation of this product for a lithotripsy procedure.The doctor noted that the cause of the infection could not be differentiated between this product, the installation procedure or how the patient cared for themselves post-procedure.It was reported that the patient was successfully treated with iv antibiotics.

• Brand Name: ORCHESTRA HYDROPHILIC GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• MDR Report Key: 11610930
• Report Number: 9610711-2021-00024
• Device Sequence Number: 14455354
• Product Code: OCY
• UDI-Device Identifier: 00884450143315
• UDI-Public: 00884450143315
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 04/13/2023
• Device Model Number: AEAD351002
• Device Catalogue Number: AEAD35
• Device Lot Number: K1815994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/02/2021
• 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