MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558640
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.No damage was found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole in the proximal section of the body of the balloon.It is possible that the technique used by the physician or the interaction with the scope during the ercp procedure, could have caused the pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 pro wireguided dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noticed that the balloon was leaking.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that this balloon had a pinhole; therefore, this is now an mdr reportable event.
Additional Manufacturer Narrative
Correction: block h6 and h10 block h6: problem code 1504 captures the reportable investigation finding of balloon pinhole.Block h10: investigation result a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.No damage was found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole in the proximal section of the body of the balloon.It is possible that the technique used by the physician or the interaction with the scope during the ercp procedure, could have caused the pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noticed that the balloon was leaking.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that this balloon had a pinhole; therefore, this is now an mdr reportable event (see block h10 for investigation details).

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11072207
• Report Number: 3005099803-2020-06381
• Device Sequence Number: 2788593
• Product Code: FGE
• UDI-Device Identifier: 08714729797524
• UDI-Public: 08714729797524
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 07/06/2022
• Device Model Number: M00558640
• Device Catalogue Number: 5864
• Device Lot Number: 0024219473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1