MAUDE Adverse Event Report: CODMAN & SHURTLEFF CATHETER WITH TAPERED CONNECTOR; ARTERIAL CATHETER

Model Number	IP37957
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intera oncology is aware of the use of the tapered catheter in the ide study at the reporter's facility.Patient information and lot number of the device is unknown at this time, and will be added to this report in a supplemental report when obtained.Four separate reports are filed from this complaint as it is known that there are four separate incidents with the tapered catheter.Intera oncology is aware that the catheter is being in the ide study with an off-label product and did not advise on specific action pertaining to the off-label use of the product.Further information obtained will be added to a supplemental report.
Event or Problem Description
During a conversation between the reporting physician and intera on 04 sept 2020, the reporter stated they were having issues with codman tapered catheter for hai patients using the medtronic synchromed ii pump.Follow up communication between intera and the reporter ensued and it was eventually discussed that there were 4 patients out of 310 that had tears in the tapered catheter.The tapered catheter comes with a barbed connector and is used to connect the catheters.They indicated that the connection between the catheters was not an issue.After several months (ranging from 3-20 months for each patient), the metal flange on the barbed connector would tear through the tapered catheter, and confirmed by either nuclear medicine or dye study.Three patients had finished adjuvant therapy and thus there was no adverse event reported at this time.One patient had therapy interruped due to the clot in the catheter and thus was unable to continue adjuvant therapy.The reporter stated that they believed that the tear was not caused by a defect in the catheter, but was caused by the acute angle of placement of the connector between the tapered catheter and the medtronic synchromed ii pump catheter, which is a shorter catheter.They also reported that after many years of performing hai surgery with the codman pump, they have never had this issue with the tapered catheter.They reported to intera that they may reach out to medtronic to determine if a longer medtronic catheter is available.
Additional Manufacturer Narrative
Reporter unable to provide patient information.
Event or Problem Description
During a conversation between the reporting physician and intera on (b)(6) 2020, the reporter stated they were having issues with codman tapered catheter for hai patients using the medtronic synchromed ii pump.Follow up communication between intera and the reporter ensued and it was eventually discussed that there were 4 patients out of 310 that had tears in the tapered catheter.The tapered catheter comes with a barbed connector and is used to connect the catheters.They indicated that the connection between the catheters was not an issue.After several months (ranging from 3-20 months for each patient), the metal flange on the barbed connector would tear through the tapered catheter, and confirmed by either nuclear medicine or dye study.Three patients had finished adjuvant therapy and thus there was no adverse event reported at this time.One patient had therapy interrupted due to the clot in the catheter and thus was unable to continue adjuvant therapy.The reporter stated that they believed that the tear was not caused by a defect in the catheter, but was caused by the acute angle of placement of the connector between the tapered catheter and the medtronic synchromed ii pump catheter, which is a shorter catheter.They also reported that after many years of performing hai surgery with the codman pump, they have never had this issue with the tapered catheter.They reported to intera that they may reach out to medtronic to determine if a longer medtronic catheter is available.

• Brand Name: CATHETER WITH TAPERED CONNECTOR
• Common Device Name: ARTERIAL CATHETER
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 10623869
• Report Number: 3015537318-2020-00010
• Device Sequence Number: 11585126
• Product Code: LKK
• UDI-Device Identifier: 10886704044086
• UDI-Public: 10886704044086
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IP37957
• Device Catalogue Number: IP37957
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other