MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA POWER INJECTABLE PORT; POWER INJECTABLE PORT AND CATHETER

Model Number H965451190

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

Dhr review: the quality records for the lot 134854000 are complete and in order.No non-conformity was recorded for this lot number.No similar complaint has been recorded for this lot of xcela power injectable port.More generally, no case of allergic reaction with plastic/titanium implants has been already reported to us.The reported complaint seems to be an isolated incident.Biocompatibility review: all materials used in the xcela power injectable plastic/titanium port are often used in biomedical area and have no contraindications to be use in a long term implantable device.To demonstrate the biocompatibility of the xcela power injectable plastic/titanium port, we performed some biocompatibility tests according to the iso 10993-1.Among the biocompatibility tests the sensitization and the irritation or intracutaneous reactivity have been tested.The xcela power injectable titanium ports were qualified as non-sensitizer and non-irritant medical devices.Risk management review: the risk of an allergic reaction and redness syndrome is identified in our risk analysis (according to the iso 14971) with a very low risk of occurrence.The choice of the materials and the biocompatibility tests permit us to reduce this risk as low as possible.However, we cannot completely exclude that a patient has an allergic reaction to materials.That is why in the ifu (page 5), a "known or suspected allergic response to the material" is identified as an absolute contraindications.Conclusion: the material of the xcela power injectable plastic titanium ports is known to be often chosen in medical device implants for its biocompatibility.This material is currently used in the implantation area and is recognized as fully capable of being implanted in the soft tissues without time limit.The biocompatibility of the full medical device has been tested and demonstrated by a series of tests in conformity with iso 10993-1.However it cannot be completely excluded that a patient has an allergic reaction to materials.

Event Description

The patient is having redness and swelling and an allergic reaction to the port.She went to her allergist.

• Brand Name: XCELA POWER INJECTABLE PORT
• Type of Device: POWER INJECTABLE PORT AND CATHETER
• Manufacturer (Section D): PFM MEDICAL CPP SA; allée du quartz 9; la chaux-de-fonds, 2300 ; SZ 2300
• Manufacturer (Section G): PFM MEDICAL CPP SA; allée du quartz 9; la chaux-de-fonds, 2300 ; SZ 2300
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008
• MDR Report Key: 8313053
• MDR Text Key: 135353807
• Report Number: 2032582-2016-00010
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00764011098535
• UDI-Public: 0764011098535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: H965451190
• Device Catalogue Number: H965451190
• Device Lot Number: 134854000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2012
• 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): Required Intervention
• Patient Age: 35 YR