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

Model Number	M00558400
Medical Device Problem Codes	Break (1069); Crack (1135); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used during an endoscopic dilation procedure performed on (b)(6) 2024.During preparation outside the patient, the product was unpacked, and it was found that the catheter was broken.The procedure was completed with a second cre wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on january 2, 2025.H11: (additional information): it was reported that the catheter was found to be broken when unpacked, and the reported event may have suggested that the catheter break during preparation.Additional information was received from the customer on january 2, 2025, that the catheter did not break into two separate pieces but instead the catheter cracked.The catheter leaks/tears are unlikely to cause or contribute to a serious injury or death if the device is exchanged, this may cause a clinically insignificant delay of procedure, but the event is unlikely to cause or contribute to patient injury.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.If additional information becomes available, it will be assessed at that time.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used during an endoscopic dilation procedure performed on (b)(6) 2024.During preparation outside the patient, the product was unpacked, and it was found that the catheter was broken.The procedure was completed with a second cre wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 2, 2025.It was reported that the catheter was cracked and did not break into two separate pieces.
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.H11: (investigation result): the returned cre wireguided dilatation balloon was analyzed, and a visual inspection found no problem with the balloon or the catheter.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter crack was not confirmed.The returned balloon found no problem with the balloon and the catheter.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used during an endoscopic dilation procedure performed on (b)(6) 2024.During preparation outside the patient, the product was unpacked, and it was found that the catheter was broken.The procedure was completed with a second cre wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 2, 2025.It was reported that the catheter was cracked and did not break into two separate pieces.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used during an endoscopic dilation procedure performed on (b)(6) 2024.During preparation outside the patient, the product was unpacked, and it was found that the catheter was broken.The procedure was completed with a second cre wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on january 2, 2025.*** it was reported that the catheter was cracked and did not break into two separate pieces.***additional information received on march 6, 2025*** it was reported that they found that the opening of the packaging bag was not sealed.This is the real event, not the catheter having cracks or fractures, so the device returned was intact.
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block h6: imdrf device code a020503 captures the reportable event of device packaging seal compromised.Block h6 has been updated based on the additional information received on march 6, 2025.Block h11: (additional mfr narrative) has been changed based on the updated product investigation result.H11: (investigation result) the returned cre wireguided dilatation balloon was analyzed, and a visual inspection found no problem with the balloon or the catheter.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging bag not sealed could not be confirmed.The device was returned in a generic plastic bag and no problem were noted on the balloon and catheter.Therefore, the most probable root cause is no problem detected.

• Brand Name: CRE WIREGUIDED
• Common Device Name: COLONOSCOPE 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21050404
• Report Number: 3005099803-2024-06704
• Device Sequence Number: 13093735
• Product Code: FDF
• UDI-Device Identifier: 08714729339335
• UDI-Public: 08714729339335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2025

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: 07/11/2025
• Device Model Number: M00558400
• Device Catalogue Number: M00558400
• Device Lot Number: 0029938489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/07/2025; 03/06/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/26/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG