MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00558480
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a hole in the device's sterile packaging.
Event or Problem Description
It was reported to boston scientific corporation that a cre wire guided dilatation balloon was being prepared for use in a colonoscopy procedure to be performed on (b)(6) 2024.During preparation, when the cre balloon was received, damage to the packaging was noticed and a hole was present in the packaging.A photo of the device packaging was provided by the customer and shows that the sterile pouch of the device packaging had multiple holes.The product was not used in any procedure.It was reported that the initial colonoscopy procedure was completed successfully with another cre wire guided dilatation balloon.The patient was not present at the time of the event and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a hole in the device's sterile packaging.Block h10: investigation results: the returned cre wireguided dilatation balloon was analyzed, and a visual and media inspection found that the sterile pouch of the device had multiple holes/indentations.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tear, rip or hole in device packaging was confirmed.The results of the analysis performed on the packaging of the returned device found that that the pouch had multiple holes/indentations.These problems could be caused due to environmental factors during the transport or storage of the device, without the proper conditions could have induced the analyzed defects.Therefore, the most probable root cause is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was being prepared for use in a colonoscopy procedure to be performed on (b)(6) 2024.During preparation, when the cre balloon was received, damage to the packaging was noticed and a hole was present in the packaging.A photo of the device packaging was provided by the customer and shows that the sterile pouch of the device packaging had multiple holes.The product was not used in any procedure.It was reported that the initial colonoscopy procedure was completed successfully with another cre wireguided dilatation balloon.The patient was not present at the time of the event and there were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19101842
• Report Number: 3005099803-2024-01704
• Device Sequence Number: 7344091
• Product Code: FDT
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 0033196134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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
• Patient Sex: Unknown