MAUDE Adverse Event Report: COOK, INC. UNKNOWN; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Internal Organ Perforation (1987); Peritonitis (2252); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

A percutaneous transhepatic cholangiole drainage catheter (ptcd) had been placed in a female patient, who has pre-existing condition of bile duct cancer in the hepatic portal region and peritoneal dissemination.The patient was in her (b)(6) when the event occurred in an unknown hospital.She was hospitalized in the unknown hospital.There was ptcd catheter placement as both ptcd and endoscope retrograde biliary drainage (erbd) was conducted.After the procedure, a radiological examination confirmed that the tip of the ptcd catheter was placed into the intestine.Sometime after this occurred, the patient was moved back to her room when she complained about stomach pain.However; because there was no evidence of peritonitis and her vital signs were stable, the physician decided to take a wait-and-see approach.Blood test conducted on the day following the procedure did not show significant inflammatory reaction.Also, xray to the abdomen did not show migration of the catheter or free air.Another blood test during a wait-and-see approach showed abrupt rise of inflammatory reaction and worsened abdominal symptom.Urgent abdominal ct performed after the blood test confirmed perforation of the digestive tract and peritonitis.Urgent operation conducted after the ct confirmed duodenal perforation and retroperitoneal abscess.There was no possibility of residual disability.Additional information has been requested but could be obtained.

Manufacturer Narrative

The event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, instructions for use (ifu), quality control (qc), specifications and trends was conducted for the purpose of this investigation.The complaint device was not returned for investigation.The device was identified by the reporter as a 7.2 fr.Drainage catheter, but no additional catalog number or lot information was provided.No additional imaging or photographs were provided.The reporter stated that the complaint device was a 7.2 fr.Drainage catheter.However, there are no drainage catheters in this french size.In researching the available drainage catheters in the 7 fr.Sizes, 5 rpn's are sold by cook in this size.The devices either have a macloc or no locking loop.The complaint reporter states, "no specific catalog or product name has been provided other than "7.2fr.Straight drainage catheter for ptcd".Due to the statement of straight drainage catheter, only the macloc devices in the list would appear as straight when pulled from the package for preparation prior to a procedure.They are later curved during use when tightening the suture.The devices with no locking loop are universal curved drainage catheters and would be curved when pulled out of the package.Therefore, it can be assumed that the complaint device had a macloc locking loop assembly.The ifu includes the warning ¿if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed".Qc instructions are in place to 100% confirm each drainage catheter is fully functional.Without a returned device, imaging or pictures from the case, or more detailed information from the physician, we cannot draw a conclusion as to the root cause of this incident.We have notified the appropriate internal personnel and will continue to monitor for similar events.

Event Description

A percutaneous transhepatic cholangio drainage catheter (ptcd) had been placed in a female patient, who has pre-existing condition of bile duct cancer in the hepatic portal region and peritoneal dissemination.The patient was in her 60's when the event occurred in an unknown hospital.She was hospitalized in the unknown hospital.There was ptcd catheter placement as both ptcd and endoscopic retrograde biliary drainage (erbd) was conducted.After the procedure, a radiological examination confirmed that the tip of the ptcd catheter was placed into the intestine.Sometime after this occurred, the patient was moved back to her room when she complained about stomach pain.However; because there was no evidence of peritonitis and her vital signs were stable, the physician decided to take a wait-and-see approach.Blood test conducted on the day following the procedure did not show significant inflammatory reaction.Also, xray to the abdomen did not show migration of the catheter or free air.Another blood test during a wait-and-see approach showed abrupt rise of inflammatory reaction and worsened abdominal symptom.Urgent abdominal ct performed after the blood test confirmed perforation of the digestive tract and peritonitis.Urgent operation conducted after the ct confirmed duodenal perforation and retroperitoneal abscess.There was no possibility of residual disability.Additional information has been requested but could not be obtained.

• Brand Name: UNKNOWN
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4662288
• MDR Text Key: 5734310
• Report Number: 1820334-2015-00166
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60'S