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	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of a hole in the package.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was received by the customer on an unknown date.Upon receipt, the products were damaged.The cardboard box was fine, not dented or anything.However, the aluminum pouch was perforated with holes, compromising the sterile barrier.The product was not used in a procedure.There were no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of a hole in the package.Block h10: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the pouch of the device had indentations.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging tear, rip or hole in device packaging can be confirmed.After analysis it was determined that the packaging of the device was returned damaged (indentations).It is possible that these damages may be related with the handling of the device after the manufacturing process, since there were no deviations occurred during the manufacturing of the product.Most likely the handling of the pouches during the storage of the device could have caused the damage reported.Therefore, the most probable root cause is cause traced to transport/storage.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was received by the customer on an unknown date.Upon receipt, the products were damaged.The cardboard box was fine, not dented or anything.However, the aluminum pouch was perforated with holes, compromising the sterile barrier.The product was not used in a procedure.There were no patient complications have been 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: 17869624
• Report Number: 3005099803-2023-05280
• Device Sequence Number: 17516228
• Product Code: FDT
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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 Expiration Date: 07/04/2026
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 0032155134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown