MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558750

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, a narrow pinhole was noticed.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, a narrow pinhole was noticed.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: visual examination of the returned complaint device found the balloon did not show visual defects and looked normal.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole on the body of the balloon.This failure is likely due to factors encountered during the procedure, such as handling or manipulation during the initial use or during the procedure that could have affected its performance and its intended purpose.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.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10273168
• MDR Text Key: 199711729
• Report Number: 3005099803-2020-02695
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2020
• Device Model Number: M00558750
• Device Catalogue Number: 5875
• Device Lot Number: 0021642346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 07/21/2020
• Patient Sequence Number: 1