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

Model Number M00566460

Device Problem Difficult to Advance (2920)

Patient Problems Death (1802); Unspecified Infection (1930); Laceration(s) (1946)

Event Date 06/19/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2015.According to the complainant, during the procedure, while the physician was pulling the peg tube through the stomach it would not come through the gastric wall.The physician had to use extreme force that resulted in a tear in the gastric wall.Reportedly, the tear led to leakage of gastric fluids into the peritoneum.According to the complainant, the incision size was "normal" (exact size unknown.) the procedure was completed with this endovive safety peg kit pull method however the patient became septic due to the leakage.The patient was transferred to a second hospital where she was seen by another physician.No treatments or medications were administered because the patient¿s family requested to withdraw care and take her home to hospice.The patient died that night at the hospital.In the physician assessment, there were many co-morbidities that led to the patient¿s death, however he feels the death was ¿50/50 related¿ to the complications of the gastric tear.

Manufacturer Narrative

Patient was transferred to a second hospital: (b)(6).(b)(4).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.

Manufacturer Narrative

A visual examination of the returned partial initial g-tube device found it had been cut at approximately 6.5 cm from the outer ring.The wire loop on the end of the dilating tip had been cut off adjacent to the tip.Two tiny cuts/ nicks/ tears were found on the tubing surface adjacent to the outer ring.The cuts/ nicks/ tears appear to be surface damage caused during the device placement.No other surface defects were noted and tubing appears to be properly extruded.The device did not present any unusual ridges in the transition area.The distal portion of the feeding tube including the bolster, was not returned.This portion most likely remained placed in the patient.The condition of the returned device could not be functionally evaluated with respect to feeding tube difficulty placing during the procedure.The most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2015.According to the complainant, during the procedure, while the physician was pulling the peg tube through the stomach it would not come through the gastric wall.The physician had to use extreme force that resulted in a tear in the gastric wall.Reportedly, the tear led to leakage of gastric fluids into the peritoneum.According to the complainant, the incision size was "normal" (exact size unknown.) the procedure was completed with this endovive safety peg kit pull method however the patient became septic due to the leakage.The patient was transferred to a second hospital where she was seen by another physician.No treatments or medications were administered because the patient's family requested to withdraw care and take her home to hospice.The patient died that night at the hospital.In the physician assessment, there were many co-morbidities that led to the patient's death, however he feels the death was "50/50 related" to the complications of the gastric tear.

• Brand Name: ENDOVIVE¿ SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4932725
• MDR Text Key: 6053360
• Report Number: 3005099803-2015-01964
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2015

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: Physician
• Device Expiration Date: 06/30/2016
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 17771263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 62 YR