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

Model Number M00558780

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a visual examination of the complaint device revealed that the exit marker was attached to the device and a little winged in the proximal section.It was also noted that the protective sleeve was found in the device.A functional evaluation as performed; the unit did not go through the scope since the balloon was already inflated.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Manufacturer report # 3005099803-2017-00426 pertains to the first cre pro gi wireguided balloon and manufacturer report # 3005099803-2017-00427 pertains to the second cre pro gi wireguided balloon.It was reported to boston scientific corporation that two cre pro gi wireguided balloons were used in the duodenal bulb during a gastroduodenal stenosis dilatation procedure performed on (b)(6) 2017.According to the complainant, after the procedure was performed, when removing the device, the exit marker of the balloon got twisted and the device could not be pulled out from the endoscope.The endoscope and the balloon were withdrawn together.Before another attempt was made to use the device for the same procedure, they cut the exit marker with scissors and that damaged the balloon.The same issue occurred with the second balloon.The procedure was completed with another cre pro gi wireguided balloon.There were no reported complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6376490
• MDR Text Key: 69020908
• Report Number: 3005099803-2017-00427
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: M00558780
• Device Catalogue Number: 5878
• Device Lot Number: 19843015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1