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

Model Number	AECD351002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2021
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the flexible tip of the orchestra peeled off during the operation and was cut inside the patient.
Additional Manufacturer Narrative
The device was received for evaluation with no labeling.The lot number was not confirmed.Upon investigation of the guide wire, it was confirmed that there was significant damage to the polyurethane jacket exposing the corewire at the distal end.No additional jacket damage was noted along the rest of the guide wire.On review of the manufacturing process for this wire, it was unlikely that the damage occurred during processing.The guidewire could not have been loaded into the hoop if the guide wire was kinked.The root cause could not be established; however, the damage is consistent with excessive force being applied to the wire.
Event or Problem Description
Additional information received further reported that the patient underwent a second procedure to remove the peeled section of the guidewire from the body.The guidewire had not been in contact with any sharp objects but had been in contact with the flexible ureterorenoscope.Laser was used in the renal pelvis, while the peeled part was located in the upper calyx, away from the laser beam.

• Brand Name: ORCHESTRA HYDROPHILIC GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12547926
• Report Number: 9610711-2021-00074
• Device Sequence Number: 16974585
• Product Code: OCY
• UDI-Device Identifier: 00884450143292
• UDI-Public: 00884450143292
• Combination Product (Y/N): N
• PMA/510(K) Number: K150927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: AECD351002
• Device Catalogue Number: AECD35
• Device Lot Number: K1815999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/1900
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown