MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number UNK-P-CRE BALLOONS FIXEDWIRE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a 20mm cre dilatation balloon was used on (b)(6) 2018 as part of the e7116 axios won drainage ide clinical trial.On (b)(6) 2018, the patient was enrolled to the study procedure.The patient had a medical history of severe acute necrotizing pancreatitis.The won (walled off necrosis) was located in the intrapancreatic.Mri indicated a 57% necrosis and on imaging the won was 14cm.It was reported that the patient began hospitalization on (b)(6) 2018.On (b)(6) 2018, the patient underwent an axios stent placement procedure transgastric to the won.Antibiotic therapy was given.Won characteristics were as follows: long axis was 14cm, short axis was 10cm, % necrotic material was 80%, and wall characteristic was soft.The axios stent was placed in the desired location without issue and a 20mm cre dilation balloon was used to dilate the stent.Necrotic drainage was visualized through the axios stent from the stomach or bowel.Bleeding occurred due to dilation with a 20mm cre dilatation balloon, though no malfunction or deficiency of the balloon was reported.It was noted that the patient had very low albumin level and that the bleeding was most likely from a small vessel just behind the balloon inside of the won.Tamponade of the bleed with the balloon was attempted but was not effective.Endoscopic suturing was then performed which immediately stopped the bleeding.It was reported that the patient is doing well.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 8028622
• MDR Text Key: 125820877
• Report Number: 3005099803-2018-61032
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-P-CRE BALLOONS FIXEDWIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR