MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00566521

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, the procedure and the placement was performed without problems which was confirmed via the endoscope that the bolster was placed properly in the stomach.On (b)(6) 2019 an abdominal ct imaging was performed it was noted the bumper part was in the abdominal cavity.From (b)(6) 2019, resistance was felt during nutrient injection and the patient expressed pain after each administration.Reportedly, based upon resistance during nutrient injection it was thought to be buried bumper syndrome.On (b)(6) 2019, the device was removed.In addition based upon picture sent it appears there was device component detachment.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, the procedure and the placement was performed without problems which was confirmed via the endoscope that the bolster was placed properly in the stomach.On (b)(6) 2019 an abdominal ct imaging was performed it was noted the bumper part was in the abdominal cavity.From (b)(6) 2019, resistance was felt during nutrient injection and the patient expressed pain after each administration.Reportedly, based upon resistance during nutrient injection it was thought to be buried bumper syndrome.On (b)(6) 2019, the device was removed.In addition based upon picture sent it appears there was device component detachment.It was also confirmed that nothing was detached inside the patient.Additional information received on 19sep2019: reportedly, the complaint device was replaced with a non bsc device.

Manufacturer Narrative

Block 10 (investigation results): the analysis of the returned device revealed that the domed peg tube was cut approximately at 6cm from the dome.The cut section was visually inspected under magnification and marks were observed on the material and these marks were in the same direction.The internal bolster/dome does not have any visual issue.The complaint could not be confirmed with the reported incident that the feeding tube was detached/separated since the only part returned was cut.It is unknown if the device broke, therefore the investigation conclusion code for this reported issue will be no problem detected.Additionally, the reported issues of bolster/button migration, bolster entrapment of device or device component and pain could not be visually or functionally verified.Directions for use mentions as possible complications, migration, blockage/occlusion, erosion/embedding into the gastric wall (buried bumper syndrome), tube clogging and pain, they are noted within the adverse events section.Therefore, the most probable cause of this complaint is known inherent risk of device since reported adverse event known and documented in the labeling.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.Block e1 (initial reporter city): (b)(6).Block h6 (device codes): problem code 2907 captures the reportable event of feeding tube detached.Problem code 4003 and 1212 captures the reportable event of buried bumper syndrome.Block h6 (patient codes): patient code 1994 captures the reportable event of pain.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(initial reporter city): (b)(6).(device codes): problem code 2907 captures the reportable event of feeding tube detached.Problem code 4003 and 1212 captures the reportable event of buried bumper syndrome.Block h6 (evaluation conclusion codes): the device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: correction to block e2 (health professional).

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, the procedure and the placement was performed without problems which was confirmed via the endoscope that the bolster was placed properly in the stomach.On (b)(6) 2019 an abdominal ct imaging was performed it was noted the bumper part was in the abdominal cavity.From (b)(6) 2019, resistance was felt during nutrient injection and the patient expressed pain after each administration.Reportedly, based upon resistance during nutrient injection it was thought to be buried bumper syndrome.On (b)(6) 2019, the device was removed.In addition based upon picture sent it appears there was device component detachment.It was also confirmed that nothing was detached inside the patient.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8893690
• MDR Text Key: 154319091
• Report Number: 3005099803-2019-04077
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00566521
• Device Catalogue Number: 6652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 09/19/2019
• Supplement Dates FDA Received: 09/05/2019; 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other