MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888123404P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, on july 8 at around 4:00 in the morning, the patient noted a leak on the pin point hole (first hole found) of the extension tube on venous side of cvc, "central venous catheter" (below the ¿y¿).It was stated that the patient woke up with blood (some bleeding) in bed and running down his arm.On july 9, early in the morning, the patient discovered a second hole which was at least an inch above the clamp (above the ¿y¿).It was said that the patient performs nocturnal hemodialysis treatment at home but the holes were noticed when no treatment was being performed.The catheter was not repaired.The catheter was noted to be felt somewhat softer/malleable than usual.There was no luer adapter issue.Clamps were not moved to a new location after each treatment, however, the clamp were moved on occasion; every few weeks.2% of chlorehexidine without alcohol was the cleaning agent used on the device which was allowed to dry.No ointment was in use.Tego was not utilized.Insertion site was treated prior to product placement with chlorhexadine.Other products in use were 2% chlorhexidine without alcohol, 3m tegaderm advanced dressing and f resenius bloodlines.There was a blood loss of 10ml but no blood transfusion was required.A line replacement was not possible for (b)(6) and therefore the line had been clamped and covered with occlusive dressing.The product was explanted and replaced as inter vention on (b)(6) to resolve the issue.There was no reported patient injury.
Event or Problem Description
According to the reporter, during use, on (b)(6) at around 4:00 in the morning, the patient noted a leak on the pin point hole (first hole was found during nocturnal home hemodialysis) of the extension tube on venous side of cvc, "central venous catheter" (below the ¿y¿).It was stated that the patient woke up with blood (some bleeding) in bed and running down his arm.On (b)(6) , early in the morning, the patient discovered a second hole which was at least an inch above the clamp (above the "y" where the cvc splits into the arterial and venous limbs).The catheter was not repaired.The catheter was noted to be felt somewhat softer/malleable than usual.There was no luer adapter issue.Clamps were not moved to a new location after each treatment, however, the patient did move the clamp on occasion; every few weeks.2% of chlorehexidine without alcohol was the cleaning agent used on the device which was allowed to dry.No ointment was in use.Tego was not utilized.Insertion site was treated prior to product placement with chlorhexadine.Other products in use were 2% chlorhexidine without alcohol, 3m tegaderm advanced dressing and fresenius bloodlines.There was a blood loss of 10ml but no blood transfusion was required.A line replacement was not possible for (b)(6) and therefore the line had bee n clamped and covered with occlusive dressing.The product was explanted and replaced as intervention on (b)(6) to resolve the issue.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g4.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10708356
• Report Number: 3009211636-2020-00256
• Device Sequence Number: 19650083
• Product Code: MSD
• UDI-Device Identifier: 10884521157774
• UDI-Public: 10884521157774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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 Expiration Date: 05/29/2023
• Device Model Number: 8888123404P
• Device Catalogue Number: 8888123404P
• Device Lot Number: 1817700207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 152