MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558670
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	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a procedure performed on an unknown date.During the procedure, it was noted that the balloon came off and the balloon had to be retrieved from the esophagus.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a procedure performed on an unknown date.During the procedure, it was noted that the balloon came off and the balloon had to be retrieved from the esophagus.The procedure was completed at this time.There were no patient complications reported as a result of this event.***additional information received on november 22, 2021*** it was reported that the cre pro wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 10/01/2021 as no event date was reported.Block h6: device code a0501 captures the reportable event of balloon detached.Block h10: a visual and microscopic examination of the returned complaint device found that the balloon was detached from the catheter, which confirms the reported event.Additionally, the balloon was accordioned and stretched.No damage was found on the catheter of the device.The guidewire was not returned with the device.It is possible that factors encountered during the procedure, such as the interaction with scope inside the esophagus, it is probable that some friction and force applied over the balloon could make that it separated from the catheter for this reason the internal lumen of the balloon was stretched and by the same issue the balloon got the accordioned shape.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a procedure performed on an unknown date.During the procedure, it was noted that the balloon came off and the balloon had to be retrieved from the esophagus.The procedure was completed at this time.There were no patient complications reported as a result of this event.Additional information received on november 22, 2021: it was reported that the cre pro wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure.
Additional Manufacturer Narrative
Block h2: additional information: blocks b5 (describe event or problem), d7a (reprocessed/reused), and h8 (usage of device).Block b3: date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Block h6: device code a0501 captures the reportable event of balloon detached.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12836755
• Report Number: 3005099803-2021-05920
• Device Sequence Number: 4638749
• Product Code: FGE
• UDI-Device Identifier: 08714729797555
• UDI-Public: 08714729797555
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• 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,Followup
• Report Date (Section B): 12/23/2021

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: 11/02/2023
• Device Model Number: M00558670
• Device Catalogue Number: 5867
• Device Lot Number: 0026449528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 12/07/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/01/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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