MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451404V5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This is one of two products involved with the reported event.The medical device reporting reference number for the other event is 9616099-2020-03544.
Event or Problem Description
During an angioplasty, a 4f 65cm tempo universal flush (uf) with 5 side holes (sh) was inserted normally through a sheath but while flushing, the physician did not see the contrast properly.When he withdrew the catheter, he noticed that it was damaged and out of order.The damage was noted after withdrawing the catheter, it was compressed/crushed and was torn.The catheters were not intact but was removed in one piece, as there were no fragments left inside the body.It happened with 2 catheters with the same lot number.The device was stored and handled as per instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty in removing the products from the packaging.There were no anomalies noted when the device was taken out of the package.There was no difficulty in removing the stylet or any of the sterile packaging components.The device was not re-sterilized.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.There were no difficulty or resistance during prep.There were no difficulty or resistance during insertion of dilator.There were no difficulty or resistance during insertion over the wire.There were no difficulty or resistance during removal of dilator.There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance felt while advancing the device.There was no excessive torqueing used during advancement/delivery of the device.There was kink/bent noted after the device was removed from the patient.There was unusual force used during the procedure.There was no patient injury reported.The procedure was completed using a 3rd tempo catheter with the same lot number.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.The devices will be returned for evaluation.Other additional procedural details were requested but were unknown.
Additional Manufacturer Narrative
During an angioplasty, two 4f tempo catheter was inserted normally through a sheath but while flushing, the physician did not see the contrast properly.When he withdrew the catheters, he noticed that it was damaged and out of order.The damage was noted after withdrawing the catheters.The catheters were compressed/crushed and torn.The catheters were removed not intact but in one piece (i.E.No fragments left inside the body).The devices were stored, handled, and prepped as per instructions for use (ifu).There were no damages noted to the products' packaging upon inspection prior to use.There was no difficulty in removing the products from the packaging.There were no anomalies noted when the devices were taken out of the package.There was no difficulty in removing the stylet or any of the sterile packaging components.The products were not re-sterilized.There were no anomalies noted during or after the devices were prepped.There was no difficulty or resistance during prep.There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance felt while advancing the device.There was no excessive torqueing used during advancement/delivery of the device.There was a kink/bend noted after the device was removed from the patient.There was unusual force used during the procedure.There was no patient injury reported.The procedure was completed using a 3rd tempo catheter with the same lot number.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.Other additional procedural details were requested but were unknown.(b)(4) non-sterile units of tempo catheters (cath tempo 4f uf 65cm 5sh) were received for analysis.The device corresponding to this complaint was unpacked in order to proceed with the product evaluation.During the visual inspection, several kinked/bent conditions were observed on the body of the catheter located at 4, 4.8, 18.8, and 45.5 cm from the distal tip.A cracked area was observed at 5.6 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od) and results were found within specification.Per microscopic analysis, results showed the torn area of the tempo catheter presented evidence of scratch marks along the torn area on the body/shaft material.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft could have probably led to the torn condition found on the received device.It seems the body/shaft material near the rupture was torn with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17876838 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.For the first returned catheter, the reported ¿catheter (body/shaft) ¿ cracked in patient¿ was confirmed since cracked areas were found on visual and microscopic analysis.The reported ¿catheter (body/shaft) ¿ compressed/crushed in patient¿ was not confirmed since visual analysis only revealed kinked/bent areas on the body of the catheter.The scratch marks found on the returned catheter are commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft could have potentially led to the cracked condition found on the received device.Per the instructions for use (ifu), although not intended as a mitigation, ¿exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the product analyses nor the phr review results suggest that the damages on the returned catheters could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9783097
• Report Number: 9616099-2020-03545
• Device Sequence Number: 2511988
• Product Code: DQO
• UDI-Device Identifier: 20705032007730
• UDI-Public: 20705032007730
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 06/30/2022
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17876838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHEATH.