MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CRE PRO WIREGUIDED 15-18MM BALLOON DILATOR; DILATOR, ESOPHAGEAL

Model Number 08714729797586

Device Problems Entrapment of Device (1212); Contamination /Decontamination Problem (2895); Device Dislodged or Dislocated (2923)

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

Event Date 01/16/2019

Event Type  Injury  

Event Description

During an egd, a boston scientific cre pro wire guided 15-18mm balloon dilator was used and the dilation was done without incident.At some point during the removal of the balloon dilator from the scope, a plastic/rubber flexible cylindrical piece (approximately 1.5" to 2" in length) from the dilator was retained in the channel of the scope without the knowledge of any of the parties involved.The scope was processed per protocol and passed all applicable testing , yet the piece remained in the channel of the scope.It was not discovered until the same scope was used for another egd procedure (on the patient listed in this report), when it became partially dislodged with a biopsy forceps that was being introduced to the channel of the scope.The remaining product of that particular make and model of balloon dilator was removed from the operating room suites for return to the manufacturer.

• Brand Name: BOSTON SCIENTIFIC CRE PRO WIREGUIDED 15-18MM BALLOON DILATOR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8297028
• MDR Text Key: 135562885
• Report Number: MW5083621
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729797586
• UDI-Public: 01087147297975861719073110195442
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 08714729797586
• Device Catalogue Number: M00558700
• Device Lot Number: 19544203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 86